Data Composite

Drug Recalls

Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.

Ascend Laboratories, LLC

US Class II Ongoing · initiated 2024-12-12

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Ascend Laboratories, LLC

US Class II Ongoing · initiated 2024-12-12

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

GNMart LLC

US Class I Ongoing · initiated 2024-12-12

Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.

Buy-Herbal

US Class I Ongoing · initiated 2024-12-12

Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine

Akron Pharma, Inc.

US Class III Ongoing · initiated 2024-12-12

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc.

US Class III Ongoing · initiated 2024-12-12

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc.

US Class III Ongoing · initiated 2024-12-12

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc.

US Class III Ongoing · initiated 2024-12-12

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc.

US Class III Ongoing · initiated 2024-12-12

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc.

US Class III Ongoing · initiated 2024-12-12

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc.

US Class III Ongoing · initiated 2024-12-12

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Vitamin A acid

Canada Type II Ongoing · initiated 2024-12-12

Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-12-11

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-12-11

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Regenerative Processing Plant, LLC

US Class II Terminated · initiated 2024-12-10

Lack of Sterility Assurance

Regenerative Processing Plant, LLC

US Class II Terminated · initiated 2024-12-10

Lack of Sterility Assurance

VIONA PHARMACEUTICALS INC

US Class II Ongoing · initiated 2024-12-10

Crystallization

VIONA PHARMACEUTICALS INC

US Class II Ongoing · initiated 2024-12-10

Crystallization

SANDOZ FESOTERODINE FUMARATE

Canada Type II Ongoing · initiated 2024-12-09

Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…

Aurobindo Pharma USA Inc

US Class II Ongoing · initiated 2024-12-06

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Breckenridge Pharmaceutical, Inc

US Class II Ongoing · initiated 2024-12-06

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Amerisource Health Services LLC

US Class II Ongoing · initiated 2024-12-06

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Amerisource Health Services LLC

US Class II Ongoing · initiated 2024-12-06

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Amerisource Health Services LLC

US Class II Ongoing · initiated 2024-12-06

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Breckenridge Pharmaceutical, Inc

US Class II Ongoing · initiated 2024-12-06

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.