US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Estradiol Valerate 10mg/Ml

Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Well Care Compounding Pharmacy D-0982-2016
Class II · Moderate risk Terminated

Estradiol Cypionate 10 Mg/Ml

Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Well Care Compounding Pharmacy D-0981-2016
Class II · Moderate risk Terminated

ATROPINE SULFATE 0.5% Ophthalmic Drops

Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Well Care Compounding Pharmacy D-0980-2016
Class II · Moderate risk Terminated

Alpha Lipoic Acid 25mg/Ml

Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Well Care Compounding Pharmacy D-0979-2016
Class II · Moderate risk Terminated

17-0h Progesterone 250mg/Ml

Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Well Care Compounding Pharmacy D-0978-2016
Class II · Moderate risk Terminated

Sulfacetamide Sodium Ophthalmic Solution

Reason Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability

Akorn, Inc. NDC 17478-221-12 D-0949-2016
Class II · Moderate risk Terminated

Potassium CHLORide added to 5% Dextrose Injection

Reason Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.

Pharmedium Services, LLC NDC 61553-836-11 D-0976-2016
Class II · Moderate risk Terminated

HCL 2mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1254-2016
Class II · Moderate risk Terminated

Zinc So4 1mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1253-2016
Class II · Moderate risk Terminated

Arginine 100mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1252-2016
Class II · Moderate risk Terminated

Zinc So4 10mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1251-2016
Class II · Moderate risk Terminated

Tryptophan 10mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1249-2016
Class II · Moderate risk Terminated

Tmg 100 Mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1248-2016
Class II · Moderate risk Terminated

Thiamine 100 Mg/Ml W/Pres

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1247-2016
Class II · Moderate risk Terminated

Thiamine 100 Mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1246-2016
Class II · Moderate risk Terminated

Taurine 50 Mg/Ml W/Pres.

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1240-2016
Class II · Moderate risk Terminated

Taurine 50 Mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1239-2016
Class II · Moderate risk Terminated

Selenium 200mcg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1238-2016
Class II · Moderate risk Terminated

Riboflavin 10mg/Ml

Reason Lack of Assurance of Sterility

Medaus, Inc. D-1237-2016