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

11,818 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

HydrALAZINE Hydrochloride Tablets

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Terminated Impurity / degradation The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6440-61 D-0324-2024
Class II · Moderate risk

Bicillin L-A

cGMP Deviations: Products were stored outside the drug label specifications.

Terminated Labeling / mix-up Mckesson Medical-Surgical Inc. Corporate Office NDC 60793-0701-10 D-0373-2024
Class II · Moderate risk

Rocuronium Bromide Injection

cGMP Deviations: Products were stored outside the drug label specifications.

Terminated Labeling / mix-up Mckesson Medical-Surgical Inc. Corporate Office NDC 55150-226-10 D-0371-2024
Class II · Moderate risk

Lansoprazole Delayed-Release Capsules USP

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Terminated Packaging defect NATCO Pharma Limited NDC 16571-742-41 D-0318-2024
Class II · Moderate risk

Fluocinolone Acetonide Oil

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Terminated Failed specification Glenmark Pharmaceuticals Inc., USA NDC 68462-185-56 D-0259-2024

Recalls by year