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

1,103 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2016 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Cisatracurium Besylate Injection

Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

Terminated Chemical / undeclared Fresenius Kabi USA, LLC NDC 63323-417-10 D-0819-2016
Class III · Low risk

Fenofibrate Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-835-32 D-0823-2016
Class III · Low risk

Fenofibrate Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-835-32 D-0822-2016
Class I · High risk

PHENYLephrine 1 mg/10 mL

Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.

Terminated Labeling / mix-up QuVa Pharma, Inc. D-1066-2016
Class II · Moderate risk

Ondansetron Tablets USP

Failed Impurities/Degradation Specifications; 12 month stability time point

Terminated Impurity / degradation Dr. Reddy's Laboratories, Inc. NDC 56111-153-30 D-0841-2016
Class II · Moderate risk

All Malarone

Lack of Processing Controls

Terminated cGMP deviation Reliable Rexall-A Compounding Pharmacy D-1136-2016
Class II · Moderate risk

All Nitro Paste

Lack of Processing Controls

Terminated cGMP deviation Reliable Rexall-A Compounding Pharmacy D-1130-2016

Recalls by year