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

708 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2020 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Solifenacin Succinate Tablets

CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.

Terminated cGMP deviation Breckenridge Pharmaceutical, Inc NDC 51991-894-33 D-1051-2020
Class II · Moderate risk

Solifenacin Succinate Tablets

CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.

Terminated cGMP deviation Breckenridge Pharmaceutical, Inc NDC 51991-893-33 D-1050-2020
Class II · Moderate risk

Olmesartan Medoxomil Tablets 20 mg

cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.

Terminated cGMP deviation Ascend Laboratories LLC NDC 67877-446-90 D-0828-2020
Class II · Moderate risk

Cholecalciferol

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0251-3 D-0993-2020
Class II · Moderate risk

Cholecalciferol

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0210-3 D-0992-2020
Class II · Moderate risk

Iohexol

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-1413-5 D-0979-2020
Class II · Moderate risk

Mitomycin-C

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0812-8 D-0976-2020

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