Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

948 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Ketotifen Fumarate 0.025 %

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Ongoing cGMP deviation RemedyRepack Inc. NDC 70518-1142-00 D-0577-2023
Class II · Moderate risk

LORazepam Injection

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Terminated cGMP deviation RemedyRepack Inc. NDC 17478-0040-01 D-0576-2023
Class II · Moderate risk

HyperLyte CR Injection

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8094-2 D-0755-2023
Class II · Moderate risk

HyperLyte CR Injection

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8094-1 D-0754-2023
Class II · Moderate risk

Lidocaine 2% HCl Inj

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8091-1 D-0753-2023
Class II · Moderate risk

Potassium Acetate Injection

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8078-1 D-0752-2023
Class II · Moderate risk

Msa 7.84% Msg 8.56%

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8029-1 D-0750-2023
Class II · Moderate risk

heparin added to 0.9% sodium chloride

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8100-1 D-0746-2023
Class II · Moderate risk

NORepinephrine added to dextrose 5%

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8095-1 D-0743-2023
Class II · Moderate risk

tromethamine 0.3 Molar

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8086-2 D-0741-2023
Class II · Moderate risk

heparin added to 0.9% sodium chloride

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. NDC 71285-8000-1 D-0739-2023

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