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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88905

51 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 26, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Perrigo Company PLC

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

Complete imported group

Every recalled product in this event

51 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 51

Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43

D-0579-2022
Recall number
D-0579-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
14,868 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1AK1031, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 2 of 51

Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26

D-0580-2022
Recall number
D-0580-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
117552 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0784, Exp 12/31/2022; 1CK0997, 1CK1083, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 3 of 51

Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97

D-0581-2022
Recall number
D-0581-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
4,992 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0960, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 4 of 51

Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26

D-0582-2022
Recall number
D-0582-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
4,176 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1GK0903, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 5 of 51

Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26

D-0583-2022
Recall number
D-0583-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
14,064 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1DK0917, 1GK0905, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 6 of 51

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16

D-0584-2022
Recall number
D-0584-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
22,140 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK0907, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 7 of 51

Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16

D-0585-2022
Recall number
D-0585-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
37,152 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK1276, 1FK1184, 1GK0821 and 1EK1046, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 8 of 51

Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202. NDC: 30142-818-26

D-0586-2022
Recall number
D-0586-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
3,120 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK1045, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 9 of 51

Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-26

D-0587-2022
Recall number
D-0587-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
2,832 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK1045, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 10 of 51

Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26

D-0588-2022
Recall number
D-0588-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
20,448 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK1045, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 11 of 51

Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC: 49035-959-26

D-0589-2022
Recall number
D-0589-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
30,144 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK1045, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 12 of 51

Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC: 55910-251-26

D-0590-2022
Recall number
D-0590-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
16,992 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK1001, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 13 of 51

Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26

D-0591-2022
Recall number
D-0591-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
26,832 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK1146, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 14 of 51

Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26

D-0592-2022
Recall number
D-0592-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
111,888 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0962, Exp 12/31/2022, 1CK0999, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 15 of 51

Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26

D-0593-2022
Recall number
D-0593-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
3,840 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1GK0905, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 16 of 51

Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26

D-0594-2022
Recall number
D-0594-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
14,688 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1FK1252, 1GK0905, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 17 of 51

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16

D-0595-2022
Recall number
D-0595-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
1,296 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK1274, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 18 of 51

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16

D-0596-2022
Recall number
D-0596-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
5,184 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK1274, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 19 of 51

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16

D-0597-2022
Recall number
D-0597-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
55,656 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK1274, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 20 of 51

Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16

D-0598-2022
Recall number
D-0598-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
68,688 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batches: 1FK1027, 1FK1184, 1EK1046, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 21 of 51

Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26

D-0599-2022
Recall number
D-0599-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
83760 packs

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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0794, Exp 12/31/2022, 1BK1035, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 22 of 51

Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9

D-0600-2022
Recall number
D-0600-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
561 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1EV1874, Exp 11/02/2022

Distribution pattern

Nationwide in the USA

drug · product 23 of 51

Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26

D-0601-2022
Recall number
D-0601-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
4,992 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK0998, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 24 of 51

Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26

D-0602-2022
Recall number
D-0602-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
3,024 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK0963, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 25 of 51

Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N.SEATTLE, WA 98109. NDC: 72288-703-10

D-0603-2022
Recall number
D-0603-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
37,104 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1FK1251, Exp 02/28/2023; 1BK0716, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 26 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10

D-0604-2022
Recall number
D-0604-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
3,168 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0827, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 27 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10

D-0605-2022
Recall number
D-0605-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
7,200 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0716, Exp 12/31/2022; 1FK1251, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 28 of 51

Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-511-10

D-0606-2022
Recall number
D-0606-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
21,4824 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0716, Exp 12/31/2022); 1CK0899, Exp 01/31/2023; 1FK1163, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 29 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10

D-0607-2022
Recall number
D-0607-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
3,192 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0716; Exp 12/31/2022); 1FK1251, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 30 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6378-1

D-0608-2022
Recall number
D-0608-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
9,888 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 11BK0827, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 31 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-813-10

D-0609-2022
Recall number
D-0609-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
14,784 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0716, Exp 12/31/2022; 1FK1251, 1HK1196, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 32 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10

D-0610-2022
Recall number
D-0610-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
2,664 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1FK1251, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 33 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10

D-0611-2022
Recall number
D-0611-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
89,208 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0912, Exp 12/31/2022; 1FK1251, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 34 of 51

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10

D-0612-2022
Recall number
D-0612-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
19,584 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0716, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 35 of 51

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10

D-0613-2022
Recall number
D-0613-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
1,296 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0964R, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 36 of 51

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10

D-0614-2022
Recall number
D-0614-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
26,448 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0826, Exp 12/31/2022); 1BK0964R, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 37 of 51

No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-388-10

D-0615-2022
Recall number
D-0615-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
64,512 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1FK1164, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 38 of 51

Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10

D-0616-2022
Recall number
D-0616-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
123,408 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0826, Exp 12/31/2022); 1FK1232, 1BK0964, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 39 of 51

Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

D-0617-2022
Recall number
D-0617-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
7,632 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0826, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 40 of 51

Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30

D-0618-2022
Recall number
D-0618-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
41,472 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0826, Exp 12/31/2022; 1FK1164, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 41 of 51

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-388-10

D-0619-2022
Recall number
D-0619-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
10,800 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1FK1164, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 42 of 51

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

D-0620-2022
Recall number
D-0620-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
3,744 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0826, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 43 of 51

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1

D-0621-2022
Recall number
D-0621-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
15,264 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0964, Exp 01/31/2023; 1FK1164, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 44 of 51

No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10

D-0622-2022
Recall number
D-0622-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
11,088 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0964, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 45 of 51

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10

D-0623-2022
Recall number
D-0623-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
1,560 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0964, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 46 of 51

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

D-0624-2022
Recall number
D-0624-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
36,864 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0826, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 47 of 51

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10

D-0625-2022
Recall number
D-0625-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
13,824 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1FK1233, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 48 of 51

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10

D-0626-2022
Recall number
D-0626-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
178,128 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1CK0897, 1FK1233, 1FK1232, Exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 49 of 51

Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10

D-0627-2022
Recall number
D-0627-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
79,776 botles

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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0931, Exp 12/31/2022; 1CK0900, Exp 01/31/2023; 1HK1196, Exp 02/28/2023

Distribution pattern

Nationwide in the USA

drug · product 50 of 51

Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10

D-0628-2022
Recall number
D-0628-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
2,302 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0716, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 51 of 51

Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10

D-0629-2022
Recall number
D-0629-2022
Initiated
October 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Perrigo Company PLC
Quantity
144 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: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information

Batch: 1BK0716, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

Field note

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