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

1,525 recalls · Class III, 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 III · Low risk

Phenytoin Sodium Injection

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-05 D-0070-2023
Class III · Low risk

Phenytoin Sodium Injection

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-02 D-0069-2023
Class III · Low risk

Susvimo (ranibizumab injection)

Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.

Terminated Packaging defect Genentech Inc NDC 50242-078-55 D-0025-2023
Class III · Low risk

oxyTOCIN 30 Units/500 mL

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

Terminated cGMP deviation QuVa Pharma, Inc. D-1544-2022
Class III · Low risk

Clonidine Hydrochloride Tablets

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Terminated Labeling / mix-up Unichem Pharmaceuticals USA INC NDC 29300-137-01 D-1541-2022
Class III · Low risk

Xolegel (ketoconazole)

Failed Viscosity specification: Slightly higher OOS results obtained for viscosity

Terminated Failed specification Almirall, LLC NDC 16110-080-45 D-1549-2022
Class III · Low risk

Nighttime Sleep-Aid

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

Terminated Labeling / mix-up LNK International, Inc. D-1472-2022
Class III · Low risk

Zynrelef (bupivacaine and meloxicam)

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

Terminated Packaging defect Heron Therapeutics, INC. NDC 47426-301-02 D-1335-2022
Class III · Low risk

Alprostadil Injection USP 500 mcg/mL

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Terminated Impurity / degradation Teva Pharmaceuticals USA Inc NDC 0703-1501-02 D-0988-2022

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