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

49 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2017 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Estrone USP

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation American Pharmaceutical Ingredients LLC D-0919-2017
Class II · Moderate risk

Levonorgestrel

CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

Terminated cGMP deviation Spectrum Laboratory Products, Inc. D-0882-2017
Class II · Moderate risk

Estradiol (17-B-Estradiol; Estra-1,3,5(10)

CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

Terminated cGMP deviation Spectrum Laboratory Products, Inc. D-0881-2017
Class II · Moderate risk

Estrone

cGMP Deviations: lack of quality assurance at the API manufacturer.

Terminated cGMP deviation Fagron, Inc NDC 51552-0445-2 D-0792-2017
Class II · Moderate risk

Estriol

cGMP Deviations: lack of quality assurance at the API manufacturer.

Terminated cGMP deviation Fagron, Inc NDC 52372-9292-01 D-0791-2017
Class II · Moderate risk

Estradiol

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-2261-04 D-0666-2017
Class II · Moderate risk

Estradiol

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-0869-07 D-0665-2017
Class II · Moderate risk

Estrone

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-0891-05 D-0664-2017
Class II · Moderate risk

Estriol

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Terminated cGMP deviation Medisca, Inc. NDC 38779-0732-03 D-0663-2017
Class II · Moderate risk

Testosterone Micronized

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-006-06 D-0658-2017
Class II · Moderate risk

Estrone Micronized

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-003-04 D-0657-2017
Class II · Moderate risk

Estriol Micronized

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation Qinhuangdao Zizhu Pharmaceutical, Co. D-0656-2017
Class II · Moderate risk

Estradiol Micronized Bulk

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-001-01 D-0654-2017
Class II · Moderate risk

MakeSense PHARMA

CGMP Deviations

Terminated cGMP deviation Cherry Hill Sales Co. NDC 69020-205-28 D-0483-2017

Recalls by year