Recall events
/
Event 67723
Event summary
Timeline bucket March 03, 2014
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Terra-Medica Inc.
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
22 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 22
Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1.
D-1191-2014
Recall number D-1191-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 1368 tubes
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 03051, EXP: April 2014; Batch # 13072, EXP: June 2015; Batch #21033, EXP: April 2016.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[7411]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 22
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.
D-1192-2014
Recall number D-1192-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 4860 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 1080, EXP: July 2015; Batch # 1102, EXP: Septempber 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[5958]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 22
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.
D-1193-2014
Recall number D-1193-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 7408 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 14010, EXP: December 2014; Batch # 11080, EXP: August 2015; Batch # 12092, EXP: July 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[5572]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 22
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1.
D-1194-2014
Recall number D-1194-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 4955 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 15070, EXP: June 2015; Batch # 24072, EXP: June 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8138]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 22
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1.
D-1195-2014
Recall number D-1195-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 21,445 Bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 21049, EXP: March 2014; Batch # 13059; EXP: April 2014; Batch # 09080, EXP: July 2015; Batch #15100; EXP: September 2015; Batch # 24092; EXP: August 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[7365]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 22
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2.
D-1196-2014
Recall number D-1196-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 730 10 x 1mL Cartons; 367 50 x 1 mL Cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information (10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8293]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 22
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 .
D-1197-2014
Recall number D-1197-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information (10 x 1mL) Batch # 25050, EXP: April 2015. (50 x 1mL): Batch # 25050, EXP: April 2015.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[5557]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 22
Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2.
D-1198-2014
Recall number D-1198-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information (10 x 1 mL) Portable Sips: Batch # 20010, EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010, EXP: December 2014.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8114]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 22
Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1.
D-1199-2014
Recall number D-1199-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 6120 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch #04062 , EXP: May 2017; Batch #06062 , EXP: May 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[7428]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 22
Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1.
D-1200-2014
Recall number D-1200-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 3725 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 2089; EXP: June 2014; Batch #3031 , EXP: June 2016.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8309]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 22
Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1.
D-1201-2014
Recall number D-1201-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 3066 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 25030; EXP: April 2015; Batch # 27101, EXP: Sept 2016.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8108]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 22
Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1.
D-1202-2014
Recall number D-1202-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 10,725 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 15129; EXP: November 2014; Batch #12040, EXP: March 2015; Batch #01081, EXP: August 2016.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[7356]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 22
Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2.
D-1203-2014
Recall number D-1203-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 211 10 x 1 ml vials; 152 50 x 1 vials
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information 10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[7371]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 22
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1.
D-1204-2014
Recall number D-1204-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 2147 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8132]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 22
Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.
D-1205-2014
Recall number D-1205-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 4050 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 24030; EXP: February 2015; Batch # 14062; EXP: May 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8405]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 22
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2.
D-1206-2014
Recall number D-1206-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 126 10 x 1 ml Cartons; 76 50 x 1ml Cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination.
Code information 10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[6037]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 22
Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1.
D-1207-2014
Recall number D-1207-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 8405 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 23109; EXP: September 2014; Batch # 08030; EXP: February 2015; Batch # 12032; EXP: February 2017; Batch # 26043; EXP: March 2018.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8399]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 22
Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.
D-1208-2014
Recall number D-1208-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 4770 Cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 27100; EXP: September 2015; Batch # 29100; EXP: October 2015; Batch # 25013; EXP: January 2018.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[5961]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 22
Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1.
D-1209-2014
Recall number D-1209-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 5940 Packages
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[5568]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 22
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.
D-1210-2014
Recall number D-1210-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 3440 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[5953]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 22
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2.
D-1211-2014
Recall number D-1211-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 111 10 x 1 mls; 39 50 x 1 mls
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information 10 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[8121]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 22
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1.
D-1212-2014
Recall number D-1212-2014
Initiated March 03, 2014
Classification Class II
Status Terminated
Quantity 428 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Penicillin Cross Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Penicillin Cross Contamination
Code information Batch # 08060; EXP: May 2015; Batch # 07119, EXP: August 2014; Batch # 03043, EXP: May 2018.
Distribution pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
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[5565]
FDA event record
· Exact recall-number query on openFDA