Recall events
/
Event 89464
Event summary
Timeline bucket January 24, 2022
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Ultra Seal Corporation
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
56 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 56
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
D-0464-2022
Recall number D-0464-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 3,508,200 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9491, AK9496, Exp. Date 02/2022; K9817, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12566]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 56
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
D-0465-2022
Recall number D-0465-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 313,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: K9824, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13102]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 56
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
D-0466-2022
Recall number D-0466-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 226,390 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9565, Exp. Date 04/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12342]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 56
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68
D-0467-2022
Recall number D-0467-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,236,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9495, Exp. Date 02/2022; AK9613, Exp. Date 05/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12907]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 56
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
D-0468-2022
Recall number D-0468-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 225,350 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9492, Exp. Date 02/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12587]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 56
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
D-0469-2022
Recall number D-0469-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 297,050 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9602, Exp. Date 05/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13053]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 56
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
D-0470-2022
Recall number D-0470-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 174,852 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: HY9042, Exp. Date 02/2022; HY9094, HY9112, Exp. Date 04/2022; HY9134, Exp. Date 05/2022; HY9267, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12914]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 56
Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40
D-0471-2022
Recall number D-0471-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity a) 702,240 blisters, b) 30,180 blisters
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: a) 19A043, 19A093, Exp. Date 01/2022; 19B062,19C079,19C080, Exp. Date 03/2022; 19D041, Exp. Date 04/2022; 19E035, 19E087, Exp. Date 05/2022; 19G084, Exp. Date 08/2022; 19H098, Exp. Date 09/2022 b) 19H098A, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16644]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 56
DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270
D-0472-2022
Recall number D-0472-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: a) C19065, Exp. Date 03/2022; F19081, Exp. Date 06/2022; 19H083, Exp. Date 08/2022; b) H19083, 1H9083, Exp. Date 08/2022; c) 19F081, Exp. Date 06/2022; 19083H, Exp. Date 08/2022; d) 19C065, Exp. Date 03/2022; 19081F, Exp. Date 06/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13050]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 56
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24
D-0473-2022
Recall number D-0473-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 301,842 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot#: 18M063, Exp. Date 01/2022; 19G076, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12860]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 56
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
D-0474-2022
Recall number D-0474-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity a) 9,060 bottles, b) 44,700 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12910]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 56
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
D-0475-2022
Recall number D-0475-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 2,189,232 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 18L124, 18L125, 18L126, Exp. Date 02/2022; 19C037, 19C038, 19C039, 19C040, Exp. Date 03/2022; 19D029, 19D030, Exp. Date 04/2022; 19D031, Exp. Date 06/2022; 19G047, Exp. Date 07/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12917]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 56
Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
D-0476-2022
Recall number D-0476-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,959,267 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 9708, Exp. Date 07/2022; AK9810, Exp. Date 09/2022; AK9946, K9946, Exp. Date 12/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12573]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 56
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
D-0477-2022
Recall number D-0477-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 915,770 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: A-K-9668, Exp. Date 06/2022; A-K-9475, Exp. Date 02/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12865]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 56
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
D-0478-2022
Recall number D-0478-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 673,160 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9715, K9715, Exp. Date 07/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12912]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 56
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
D-0479-2022
Recall number D-0479-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 25,776 blisters
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 19E058A, 19E058B, Exp. Date 05/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12589]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 56
Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
D-0480-2022
Recall number D-0480-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 227,010 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9436, Exp. Date 01/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13004]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 56
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
D-0481-2022
Recall number D-0481-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,351,660 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9453, Exp. Date 01/2022; AK9716, 07/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12922]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 56
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832
D-0482-2022
Recall number D-0482-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 5,107,565 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: K9770, AK9770 Exp. Date 08/2022; AK9958, K9958 Exp. Date 12/2022; AK9717, Exp. Date 07/2022; AK9522, AK9641 , Exp. Date 03/2022; AK9817, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12562]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 56
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03
D-0483-2022
Recall number D-0483-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 7,858,690 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: K9456, AK9454, 9456, AK9456, Exp. Date 01/2022; AK9524, AK9528 Exp. Date 03/2022; K9767, AK9767, Exp. Date 08/2022; AK9824, AK9823, Exp. Date 09/2022; AK9564, Exp. Date 04/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12861]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 56
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
D-0484-2022
Recall number D-0484-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 5,741,384 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 9445, AK9445, K9445, Exp. Date 01/2022; K9486, Exp. Date 02/2022; AK9708, Exp. Date 07/2022; AK9515, Exp. Date 03/2022; K9810, Exp. Date 09/2022; AK9658, Exp. Date 06/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12346]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 56
Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
D-0485-2022
Recall number D-0485-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,186,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9493, Exp. Date 02/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13044]
FDA event record
· Exact recall-number query on openFDA
drug · product 23 of 56
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
D-0486-2022
Recall number D-0486-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 301,650 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: K9708, Exp. Date 07/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13095]
FDA event record
· Exact recall-number query on openFDA
drug · product 24 of 56
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
D-0487-2022
Recall number D-0487-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 226,400 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9587, Exp. Date 02/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12852]
FDA event record
· Exact recall-number query on openFDA
drug · product 25 of 56
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
D-0488-2022
Recall number D-0488-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,188,280 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9451, Exp. Date 01/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13092]
FDA event record
· Exact recall-number query on openFDA
drug · product 26 of 56
SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
D-0489-2022
Recall number D-0489-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 122,400 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9766, Exp. Date 08/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12870]
FDA event record
· Exact recall-number query on openFDA
drug · product 27 of 56
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
D-0490-2022
Recall number D-0490-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 2,685,700 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9548, (L) 106, Exp. Date 04/2022; AK9647, (L)103, Exp. Date 06/2022; AK9598, Exp. Date 05/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12578]
FDA event record
· Exact recall-number query on openFDA
drug · product 28 of 56
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
D-0491-2022
Recall number D-0491-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,694,200 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9599, Exp. Date 05/2022; AK9648, (L) 104, Exp. Date 06/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13098]
FDA event record
· Exact recall-number query on openFDA
drug · product 29 of 56
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
D-0492-2022
Recall number D-0492-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 2,336,600 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9433, Exp. Date 01/2022; AK9749, Exp. Date 08/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12588]
FDA event record
· Exact recall-number query on openFDA
drug · product 30 of 56
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00
D-0493-2022
Recall number D-0493-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 111,300 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9698, Exp. Date 07/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12862]
FDA event record
· Exact recall-number query on openFDA
drug · product 31 of 56
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03
D-0494-2022
Recall number D-0494-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 769,200 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9434, (L)101, Exp. date 01/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12916]
FDA event record
· Exact recall-number query on openFDA
drug · product 32 of 56
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
D-0495-2022
Recall number D-0495-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 447,050 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9478, Exp. Date 02/2022; AK9799, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12354]
FDA event record
· Exact recall-number query on openFDA
drug · product 33 of 56
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
D-0496-2022
Recall number D-0496-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,309,800 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9523, K9523 Exp. Date 03/2022; AK9670, Exp. Date 06/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12921]
FDA event record
· Exact recall-number query on openFDA
drug · product 34 of 56
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68
D-0497-2022
Recall number D-0497-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 887,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9527, Exp. Date 03/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13607]
FDA event record
· Exact recall-number query on openFDA
drug · product 35 of 56
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00
D-0498-2022
Recall number D-0498-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,180,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9450, Exp. Date 01/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12592]
FDA event record
· Exact recall-number query on openFDA
drug · product 36 of 56
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
D-0499-2022
Recall number D-0499-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 533,100 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: K9495, Exp. Date 02/2022; AK9614, Exp. Date 05/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12582]
FDA event record
· Exact recall-number query on openFDA
drug · product 37 of 56
MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
D-0500-2022
Recall number D-0500-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 307,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9768, Exp. Date 08/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12576]
FDA event record
· Exact recall-number query on openFDA
drug · product 38 of 56
PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
D-0501-2022
Recall number D-0501-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 19E021, 19E022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13096]
FDA event record
· Exact recall-number query on openFDA
drug · product 39 of 56
PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
D-0502-2022
Recall number D-0502-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity a)131,112 packets, b) 8,064 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: a)19E030, b)19E031
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12855]
FDA event record
· Exact recall-number query on openFDA
drug · product 40 of 56
PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
D-0503-2022
Recall number D-0503-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity a) 113,040 packets, b) 7,132 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: a)19E032, b)19E033
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12580]
FDA event record
· Exact recall-number query on openFDA
drug · product 41 of 56
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
D-0504-2022
Recall number D-0504-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity a) 156,096 packets, b) 9,648 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: a)19E021, b)19E022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13001]
FDA event record
· Exact recall-number query on openFDA
drug · product 42 of 56
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895
D-0505-2022
Recall number D-0505-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 241,560 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 18L124, Exp. Date 02/2022; 19D029, Exp. Date 04/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12344]
FDA event record
· Exact recall-number query on openFDA
drug · product 43 of 56
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
D-0506-2022
Recall number D-0506-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 90,072 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 19C038C, Exp. Date 03/2022; 19G047C, Exp. Date 07/2022; 18L124C, Exp. Date 02/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12911]
FDA event record
· Exact recall-number query on openFDA
drug · product 44 of 56
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124
D-0507-2022
Recall number D-0507-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,1401,641 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9796, Exp. Date 09/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12919]
FDA event record
· Exact recall-number query on openFDA
drug · product 45 of 56
Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
D-0508-2022
Recall number D-0508-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,486,050 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9566, Exp. Date 04/2022; AK9612, Exp. Date 05/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12458]
FDA event record
· Exact recall-number query on openFDA
drug · product 46 of 56
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
D-0509-2022
Recall number D-0509-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 223,090 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9695, Exp. Date 07/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13041]
FDA event record
· Exact recall-number query on openFDA
drug · product 47 of 56
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
D-0510-2022
Recall number D-0510-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 225,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9841, Ex. Date 10/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13056]
FDA event record
· Exact recall-number query on openFDA
drug · product 48 of 56
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
D-0511-2022
Recall number D-0511-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,019,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9475, Exp. Date 02/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12355]
FDA event record
· Exact recall-number query on openFDA
drug · product 49 of 56
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
D-0512-2022
Recall number D-0512-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 216,000 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9640, Exp. Date 03/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12356]
FDA event record
· Exact recall-number query on openFDA
drug · product 50 of 56
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
D-0513-2022
Recall number D-0513-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 448,300 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9859, Exp. Date 10/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12357]
FDA event record
· Exact recall-number query on openFDA
drug · product 51 of 56
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
D-0514-2022
Recall number D-0514-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 409,890 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9486, Exp. Date 02/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13051]
FDA event record
· Exact recall-number query on openFDA
drug · product 52 of 56
ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
D-0515-2022
Recall number D-0515-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 1,474,050 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9797, AK9254
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12461]
FDA event record
· Exact recall-number query on openFDA
drug · product 53 of 56
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
D-0516-2022
Recall number D-0516-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity a) 308,928 blisters b) 29,808 blisters
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: a) 19B050A, 19B050B, 19B050C, 19B050D, 19B050E, Exp. Date 06/2022; 19F063, 19F063A, 19F063B, Exp. Date 08/2022; b) 19B050-A, Exp. Date 06/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12575]
FDA event record
· Exact recall-number query on openFDA
drug · product 54 of 56
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
D-0517-2022
Recall number D-0517-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 40,344 blisters
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: 19B011, 19B012, 19B012A, 19E023, Exp. Date 05/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13006]
FDA event record
· Exact recall-number query on openFDA
drug · product 55 of 56
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
D-0518-2022
Recall number D-0518-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 447,190 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9651, Exp. Date 06/2022; AK9437, Exp. Date 01/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12574]
FDA event record
· Exact recall-number query on openFDA
drug · product 56 of 56
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
D-0519-2022
Recall number D-0519-2022
Initiated January 24, 2022
Classification Class II
Status Terminated
Quantity 227,010 packets
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP deviations
Code information Lot #: AK9436, Exp. Date 01/2022
Distribution pattern Nationwide within the United States
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12348]
FDA event record
· Exact recall-number query on openFDA
