Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

14,806 recalls, 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 I · High risk

Marcaine (bupivacaine HCl)

Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-1559-30 D-1161-2014
Class II · Moderate risk

Phenytoin Oral Suspension USP 125mg/5mL

Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

Terminated Packaging defect VistaPharm, Inc. NDC 66689-036-50 D-342-2014
Class II · Moderate risk

Oxygen

Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.

Terminated Failed specification Airgas Medical Services D-386-2014
Class II · Moderate risk

Ropinirole

Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.

Terminated Cross-contamination Sandoz, Inc NDC 0781-5780-92 D-66458-1
Class II · Moderate risk

Metformin Hydrochloride USP

CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.

Terminated cGMP deviation Betachem, Inc. D-406-2014
Class II · Moderate risk

Dexedrine¿

Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

Terminated Dissolution failure Amedra Pharmaceuticals LLC NDC 52054-514-09 D-385-2014
Class II · Moderate risk

Albuterol Sulfate Inhalation Solution

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

Terminated Sterility / contamination Nephron Pharmaceuticals Corp. NDC 0487-9501-25 D-66462-001
Class III · Low risk

Potassium Chloride

Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.

Terminated Labeling / mix-up Cardinal Health D-0489-2015

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