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

381 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 II · Moderate risk

Pluvicto

CGMP deviations

Ongoing cGMP deviation Advanced Accelerator Applications USA, Inc. NDC 69488-0010-61 D-0007-2025
Class II · Moderate risk

Glenmark

CGMP Deviations

Ongoing cGMP deviation Glenmark Pharmaceuticals Inc., USA NDC 68462-626-52 D-0621-2024
Class II · Moderate risk

suntegrity

CGMP Deviations

Ongoing cGMP deviation Synchronicity Spa INC, Dba Sunte D-0589-2024
Class II · Moderate risk

Sertraline Tablets

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Ongoing cGMP deviation Legacy Pharmaceutical Packaging LLC NDC 68645-523-54 D-0205-2024
Class II · Moderate risk

Gynazole-1

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

Ongoing cGMP deviation Padagis US LLC D-0081-2024
Class II · Moderate risk

Dry Eye Relief Lubricant Eye Drops

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Ongoing cGMP deviation K.C. Pharmaceuticals, Inc NDC 49035-280-02 D-0898-2023
Class II · Moderate risk

Original Eye Drops

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Ongoing cGMP deviation K.C. Pharmaceuticals, Inc NDC 49348-037-29 D-0897-2023
Class II · Moderate risk

HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge

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 SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0776-2023
Class II · Moderate risk

Safe tussin PM

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC D-0775-2023
Class II · Moderate risk

Pin-Away PYRENTAL PAMOATE

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC NDC 70309-080-02 D-0774-2023

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