US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class I · High risk Terminated

Ceftriaxone for Injection USP

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Lupin Pharmaceuticals Inc. NDC 68180-644-01 D-0358-2019
Class I · High risk Terminated

Ceftriaxone for Injection USP

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Lupin Pharmaceuticals Inc. NDC 68180-633-01 D-0357-2019
Class I · High risk Terminated

Ceftriaxone for Injection USP

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Lupin Pharmaceuticals Inc. NDC 68180-622-01 D-0356-2019
Class I · High risk Terminated

Ceftriaxone for Injection USP

Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Lupin Pharmaceuticals Inc. NDC 68180-611-01 D-0355-2019
Class III · Low risk Terminated

Temozolomide Capsules

Reason Failed Dissolution Specifications

Amerigen Pharmaceuticals Inc. NDC 43975-256-14 D-0345-2019
Class III · Low risk Terminated

Temozolomide Capsules

Reason Failed Dissolution Specifications

Amerigen Pharmaceuticals Inc. NDC 43975-253-05 D-0344-2019
Class II · Moderate risk Terminated

Oxygen

Reason CGMP Deviations

Roberts Home Medical LLC D-1002-2019
Class II · Moderate risk Terminated

Cidofovir Dihydrate

Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

LGM Pharma LLC D-0486-2019
Class II · Moderate risk Terminated

Folic Acid

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0481-2019
Class II · Moderate risk Terminated

Zinc Sulfate

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0480-2019
Class II · Moderate risk Terminated

Glycyrrhizic Acid

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0479-2019
Class II · Moderate risk Terminated

Dexpanthenol

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0478-2019
Class II · Moderate risk Terminated

Lysine HCl

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0477-2019
Class II · Moderate risk Terminated

Pyridoxine HCl

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0475-2019
Class II · Moderate risk Terminated

Procaine HCl

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0474-2019
Class II · Moderate risk Terminated

Trim Calm

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0473-2019
Class II · Moderate risk Terminated

Folic Acid

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0472-2019
Class II · Moderate risk Terminated

Zinc Sulfate

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0471-2019
Class II · Moderate risk Terminated

Myer's Cocktail

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0470-2019
Class II · Moderate risk Terminated

Niacinamide injection

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0469-2019
Class II · Moderate risk Terminated

ICB-Complex

Reason Lack of sterility assurance.

Promise Pharmacy, LLC D-0466-2019