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.

Mylan Institutional, Inc.

US Class II Ongoing · initiated 2024-11-19

Subpotent and Superpotent Drug

PREGABALIN

Canada Type II Ongoing · initiated 2024-11-19

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

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Viatris Inc

US Class II Ongoing · initiated 2024-11-18

Superpotent Drug and Subpotent Drug: potency failures obtained

Endo USA, Inc.

US Class I Ongoing · initiated 2024-11-18

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Endo USA, Inc.

US Class I Ongoing · initiated 2024-11-18

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Endo USA, Inc.

US Class I Ongoing · initiated 2024-11-18

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Endo USA, Inc.

US Class I Ongoing · initiated 2024-11-18

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Evaric Pharmaceuticals Inc.

US Class II Terminated · initiated 2024-11-15

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.

Amerisource Health Services LLC

US Class II Ongoing · initiated 2024-11-14

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

Amerisource Health Services LLC

US Class II Ongoing · initiated 2024-11-14

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

Zydus Pharmaceuticals (USA) Inc

US Class III Ongoing · initiated 2024-11-14

Labeling: Not Elsewhere Classified - Wrong NDC number

Amerisource Health Services LLC

US Class II Ongoing · initiated 2024-11-14

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

LNK International, Inc.

US Class II Terminated · initiated 2024-11-14

CGMP Deviations: Released product should have been rejected.

Keystone Industries

US Class II Terminated · initiated 2024-11-14

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the…

Keystone Industries

US Class II Terminated · initiated 2024-11-14

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the…