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.

Zydus Pharmaceuticals (USA) Inc

US Class II Ongoing · initiated 2025-10-23

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

Zydus Pharmaceuticals (USA) Inc

US Class II Ongoing · initiated 2025-10-22

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acc…

Zydus Pharmaceuticals (USA) Inc

US Class II Ongoing · initiated 2025-10-22

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acc…

Zydus Pharmaceuticals (USA) Inc

US Class II Ongoing · initiated 2025-10-22

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acc…

Bristol-Myers Squibb Company

US Class II Ongoing · initiated 2025-10-21

Lack of Assurance of Sterility.

Kenvue Brands LLC

US Class II Ongoing · initiated 2025-10-21

Defective Container

Golden State Medical Supply Inc.

US Class II Ongoing · initiated 2025-10-20

Failed Dissolution Specifications

Imprimis NJOF, LLC

US Class III Ongoing · initiated 2025-10-20

Subpotent Drug

ANTHONY TRINH, 123Herbals LLC

US Class I Ongoing · initiated 2025-10-20

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

Aero Healthcare

US Class II Ongoing · initiated 2025-10-17

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The in…

Amerisource Health Services LLC

US Class II Ongoing · initiated 2025-10-16

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable …

Amerisource Health Services LLC

US Class II Ongoing · initiated 2025-10-16

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable …

Amerisource Health Services LLC

US Class II Ongoing · initiated 2025-10-16

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable …

Isologic Innovative Radiopharmaceuticals Products

Canada Type III Ongoing · initiated 2025-10-16

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

ProRx LLC

US Class II Ongoing · initiated 2025-10-15

Lack of Assurance of Sterility

ProRx LLC

US Class II Ongoing · initiated 2025-10-15

Lack of Assurance of Sterility

ProRx LLC

US Class II Ongoing · initiated 2025-10-15

Lack of Assurance of Sterility

ProRx LLC

US Class II Ongoing · initiated 2025-10-15

Lack of Assurance of Sterility

ProRx LLC

US Class II Ongoing · initiated 2025-10-15

Lack of Assurance of Sterility

ProRx LLC

US Class II Ongoing · initiated 2025-10-15

Lack of Assurance of Sterility

ProRx LLC

US Class II Ongoing · initiated 2025-10-15

Lack of Assurance of Sterility

FARMAKEIO OUTSOURCING LLC

US Class II Ongoing · initiated 2025-10-14

CGMP Deviations: Potential presence of metal particulate matter

FARMAKEIO OUTSOURCING LLC

US Class II Ongoing · initiated 2025-10-14

CGMP Deviations: Potential presence of metal particulate matter

FARMAKEIO OUTSOURCING LLC

US Class II Ongoing · initiated 2025-10-14

CGMP Deviations: Potential presence of metal particulate matter

FARMAKEIO OUTSOURCING LLC

US Class II Ongoing · initiated 2025-10-14

CGMP Deviations: Potential presence of metal particulate matter