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

166 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

Gelato

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries NDC 68400-352-30 D-0137-2025
Class III · Low risk

Hydralazine HCl Tablets

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

Terminated Impurity / degradation The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6441-61 D-0045-2025
Class II · Moderate risk

Ramipril Capsules USP 10 mg

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Terminated Unapproved drug Lupin Pharmaceuticals Inc. NDC 68180-591-09 D-0054-2025
Class II · Moderate risk

Ramipril Capsules USP 5 mg

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Terminated Unapproved drug Lupin Pharmaceuticals Inc. NDC 68180-590-09 D-0053-2025
Class II · Moderate risk

Ramipril Capsules USP 2.5 mg

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Terminated Unapproved drug Lupin Pharmaceuticals Inc. NDC 68180-589-09 D-0052-2025
Class III · Low risk

Triamcinolone Acetonide Cream USP

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

Terminated Wrong potency / content Padagis US LLC D-0048-2025

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