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.

Breckenridge Pharmaceutical, Inc.

US Class II Ongoing · initiated 2025-02-28

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

Breckenridge Pharmaceutical, Inc.

US Class II Ongoing · initiated 2025-02-28

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

Sigan Industries Group Inc.

US Class II Ongoing · initiated 2025-02-28

Chemical Contamination: Presence of benzene

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-02-28

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-02-28

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-02-28

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-02-28

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Amgen, Inc.

US Class II Ongoing · initiated 2025-02-27

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Amgen, Inc.

US Class II Ongoing · initiated 2025-02-27

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Sensipar (30mg, 60mg, 90mg)

Canada Type II Ongoing · initiated 2025-02-27

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…

MYLAN PHARMACEUTICALS INC

US Class II Ongoing · initiated 2025-02-25

Failed Dissolution Specifications - low dissolution results

A-S Medication Solutions LLC

US Class II Ongoing · initiated 2025-02-25

Presence of Foreign Tablets/Capsules.

Kowa Pharmaceuticals America

US Class III Completed · initiated 2025-02-24

Presence of foreign tablets/capsules

Denison Pharmaceuticals, LLC

US Class II Ongoing · initiated 2025-02-24

Chemical Contamination: Presence of benzene.

Imprimis NJOF, LLC

US Class III Ongoing · initiated 2025-02-24

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Central Admixture Pharmacy Services, Inc.

US Class I Ongoing · initiated 2025-02-20

Presence of Particulate Matter

One Source Nutrition, Inc,

US Class I Ongoing · initiated 2025-02-20

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

Turbare Manufacturing

US Class II Completed · initiated 2025-02-18

Lack of Assurance of Sterility: due to a quality control process deviation

BD ChloraPrep™ Clear - 1mL Applicator

Canada Type II Ongoing · initiated 2025-02-18

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…

CISATRACURIUM BESYLATE INJECTION USP MULTIDOSE

Canada Type III Ongoing · initiated 2025-02-18

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…

Safecor Health, LLC

US Class II Ongoing · initiated 2025-02-17

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC

US Class II Ongoing · initiated 2025-02-17

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC

US Class II Ongoing · initiated 2025-02-17

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC

US Class II Ongoing · initiated 2025-02-17

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC

US Class II Ongoing · initiated 2025-02-17

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.