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.

TEVA-Betahistine Tablets

Canada Type I Ongoing · initiated 2024-12-04

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…

RemedyRepack Inc.

US Class II Ongoing · initiated 2024-12-02

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

PDP-Benztropine

Canada Type II Ongoing · initiated 2024-11-29

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…

Florabile

Canada Type II Ongoing · initiated 2024-11-29

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…

Oridermyl

Canada Type III Ongoing · initiated 2024-11-28

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…

AvKARE

US Class II Ongoing · initiated 2024-11-27

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

AvKARE

US Class II Ongoing · initiated 2024-11-27

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

AvKARE

US Class II Ongoing · initiated 2024-11-27

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

Curium US, LLC

US Class II Terminated · initiated 2024-11-26

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

Kit for the preparation of technetium TC 99M Sestambi Injection

Canada Type I Ongoing · initiated 2024-11-26

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…

Macleods Pharmaceuticals Ltd

US Class II Ongoing · initiated 2024-11-25

Failed Impurities/Degradation Specifications

Generitech Corporation

US Class II Ongoing · initiated 2024-11-22

CGMP Deviations: Inconsistency in the water systems.

Dr. Reddy's Laboratories, Inc.

US Class III Ongoing · initiated 2024-11-22

Failed Impurities/Degradation Specifications

Provepharm Inc.

US Class II Ongoing · initiated 2024-11-22

Discoloration

Apothecus Pharmaceutical Corp.

US Class II Ongoing · initiated 2024-11-22

CGMP deviations: out of specifications for assay

Jubilant Draximage Inc., dba Jubilant Radiopharma

US Class II Ongoing · initiated 2024-11-22

Failed Stability Specifications

Benzo-Jel (Cherry)

Canada Unclassified Ongoing · initiated 2024-11-22

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…

Rising Pharma Holding, Inc.

US Class II Ongoing · initiated 2024-11-19

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

Rising Pharma Holding, Inc.

US Class II Ongoing · initiated 2024-11-19

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

Rising Pharma Holding, Inc.

US Class II Ongoing · initiated 2024-11-19

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

Mylan Institutional, Inc.

US Class II Ongoing · initiated 2024-11-19

Subpotent and Superpotent Drug

Mylan Institutional, Inc.

US Class II Ongoing · initiated 2024-11-19

Subpotent and Superpotent Drug

Mylan Institutional, Inc.

US Class II Ongoing · initiated 2024-11-19

Subpotent and Superpotent Drug

Mylan Institutional, Inc.

US Class II Ongoing · initiated 2024-11-19

Subpotent and Superpotent Drug

Mylan Institutional, Inc.

US Class II Ongoing · initiated 2024-11-19

Subpotent and Superpotent Drug