US Drug Recall Register

FDA Drug Recalls

2,277 recalls · Class II, newest first

Class II · Moderate risk Ongoing

Walgreens

Reason Chemical Contamination: Presence of benzene

Sigan Industries Group Inc. D-0274-2025
Class II · Moderate risk Ongoing

Duloxetine Delayed-Release Capsules

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

Breckenridge Pharmaceutical, Inc. NDC 51991-746-05 D-0271-2025
Class II · Moderate risk Ongoing

Duloxetine Delayed-Release Capsules

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

Breckenridge Pharmaceutical, Inc. NDC 51991-747-10 D-0270-2025
Class II · Moderate risk Ongoing

Duloxetine Delayed-Release Capsules

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

Breckenridge Pharmaceutical, Inc. NDC 51991-748-10 D-0269-2025
Class II · Moderate risk Ongoing

Neupogen

Reason 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. NDC 55513-546-01 D-0286-2025
Class II · Moderate risk Ongoing

Neupogen

Reason 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. NDC 55513-530-01 D-0285-2025
Class II · Moderate risk Ongoing

Prasugrel Tablets

Reason Failed Dissolution Specifications - low dissolution results

Mylan Pharmaceuticals INC NDC 0378-5185-93 D-0280-2025
Class II · Moderate risk Ongoing

Zapzyt

Reason Chemical Contamination: Presence of benzene.

Denison Pharmaceuticals, LLC NDC 71687-0011-1 D-0273-2025
Class II · Moderate risk Ongoing

CURAD Alcohol Prep Pads

Reason Subpotent Drug

MEDLINE INDUSTRIES, LP - Northfield NDC 53329-827-30 D-0289-2025
Class II · Moderate risk Ongoing

Medline Alcohol Prep Pads

Reason Subpotent Drug

MEDLINE INDUSTRIES, LP - Northfield NDC 53329-811-30 D-0288-2025
Class II · Moderate risk Ongoing

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe

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

Safecor Health, LLC D-0254-2025
Class II · Moderate risk Ongoing

Lorazepam 0.5 mg per 0.25 mL Oral Syringe

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

Safecor Health, LLC D-0253-2025
Class II · Moderate risk Ongoing

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe

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

Safecor Health, LLC D-0252-2025
Class II · Moderate risk Ongoing

Simethicone 20 mg per 0.3 mL Oral Syringe

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

Safecor Health, LLC D-0251-2025
Class II · Moderate risk Ongoing

Ergocalciferol - Vitamin D Supplement - 10 mcg

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

Safecor Health, LLC D-0250-2025
Class II · Moderate risk Ongoing

Iodo Blanco Iodides

Reason Defective Container: broken or leaking bottles.

World Perfumes Inc. D-0622-2025
Class II · Moderate risk Ongoing

Nelarabine Injection

Reason Failed Impurities/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc NDC 70710-1839-1 D-0256-2025
Class II · Moderate risk Ongoing

Nelarabine Injection

Reason Failed Impurities/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc NDC 70710-1726-1 D-0255-2025
Class II · Moderate risk Ongoing

ViaMed Alcohol Prep Pads

Reason Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Wuxi Medical lnstrument Factory Co., Ltd. D-0247-2025