Independent register of U.S. FDA drug recalls · updated Oct 10, 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 II · Moderate risk

Mitomycin (modified)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-657-2013
Class II · Moderate risk

Mitomycin 0.04% solution

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-656-2013
Class II · Moderate risk

Methylcobalamin 12.5 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-655-2013
Class II · Moderate risk

Methylcobalamin 1250 mcg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-654-2013
Class II · Moderate risk

Medroxyprogesterone 50 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-652-2013
Class II · Moderate risk

Medroxyprogesterone 150 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-651-2013
Class II · Moderate risk

Latanoprost 0.025% eye drop

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-650-2013
Class II · Moderate risk

Laser ophthalmic drops

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-649-2013
Class II · Moderate risk

Itraconazole 1% eye ointment

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-648-2013
Class II · Moderate risk

Injection vehicle

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-647-2013
Class II · Moderate risk

Hydroxyprogesterone 250 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-646-2013
Class II · Moderate risk

HCG 500 units/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-645-2013
Class II · Moderate risk

HCG 2000 units/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-644-2013
Class II · Moderate risk

HCG 1000 units/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-643-2013
Class II · Moderate risk

Estradiol Valerate 30 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-641-2013
Class II · Moderate risk

Estradiol Valerate 20 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-640-2013
Class II · Moderate risk

Estradiol Cypionate 5 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-639-2013
Class II · Moderate risk

Diazepam 5 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-638-2013
Class II · Moderate risk

Cyclosporine 2% ophthalmic

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-637-2013
Class II · Moderate risk

Cataract drops

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-635-2013
Class II · Moderate risk

Acetylcysteine 2 % Solution

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-634-2013
Class II · Moderate risk

Acetylcysteine 20 % solution

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-633-2013

Recalls by year