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.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class II Ongoing · initiated 2025-01-21

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impu…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class II Ongoing · initiated 2025-01-21

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impu…

Create Compounding Pharmacy - Semaglutide + Pyridoxine

Canada Type I Ongoing · initiated 2025-01-21

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

The W.S. Badger Company, Inc.

US Class III Terminated · initiated 2025-01-17

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

McKesson

US Class II Ongoing · initiated 2025-01-17

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Appco Pharma LLC

US Class III Completed · initiated 2025-01-16

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class II Terminated · initiated 2025-01-13

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

AG-Escitalopram

Canada Type II Ongoing · initiated 2025-01-13

Product quality. Verify if your product is affected.Contact the recalling firm if you have any questions about the recall.Report any health product related side…

Teva Pharmaceuticals USA, Inc

US Class II Ongoing · initiated 2025-01-10

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Johnson, S C and Son, Inc

US Class II Ongoing · initiated 2025-01-08

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

Amerisource Health Services LLC

US Class II Ongoing · initiated 2025-01-07

Presence of Foreign Tablets/Capsules

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

US Class III Completed · initiated 2025-01-07

Superpotent; sodium benzoate preservative

JAMP - ESCITALOPRAM 20mg

Canada Type II Ongoing · initiated 2025-01-07

Product quality. Verify if your product is affected.Contact the recalling firm if you have any questions about the recall.Report any health product related side…

QUETIAPINE XR

Canada Type I Ongoing · initiated 2025-01-07

Product quality. Verify if your product is affected.Contact the recalling firm if you have any questions about the recall.Report any health product related side…

Rising Pharma Holding, Inc.

US Class II Ongoing · initiated 2024-12-30

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

Rising Pharma Holding, Inc.

US Class II Ongoing · initiated 2024-12-30

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

Granules Pharmaceuticals Inc.

US Class II Terminated · initiated 2024-12-30

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Rising Pharma Holding, Inc.

US Class II Ongoing · initiated 2024-12-30

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

PMS-CINACALCET Tablets (30MG, 60 MG, 90 MG)

Canada Type I Ongoing · initiated 2024-12-30

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…

Eugia US LLC

US Class II Ongoing · initiated 2024-12-27

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Viatris Inc

US Class II Terminated · initiated 2024-12-23

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Viatris Inc

US Class II Terminated · initiated 2024-12-23

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

First Aid Beauty Ltd

US Class II Ongoing · initiated 2024-12-23

CGMP Deviations; product intended for quarantine was inadvertently distributed

Astellas Pharma US Inc.

US Class I Ongoing · initiated 2024-12-23

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Astellas Pharma US Inc.

US Class I Ongoing · initiated 2024-12-23

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules