Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2016

Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,199 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2016 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

L-Glut/L-Arg/L-Carn

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0993-2016
Class II · Moderate risk

Levocarnitine 100mg/Ml

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0992-2016
Class II · Moderate risk

Hydrogen Peroxide 3%

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0991-2016
Class II · Moderate risk

Hcg/Methylcobalamin/Folic Acid

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0990-2016
Class II · Moderate risk

1-Hcg 2000 Iu/Ml

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0989-2016
Class II · Moderate risk

1-Hcg 1000 Iu/Ml

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0988-2016
Class II · Moderate risk

Glutathione 200mg/Ml

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0987-2016
Class II · Moderate risk

Glutathione 100mg/Ml

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0986-2016
Class II · Moderate risk

Estradiol Valerate 40mg/Ml

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0984-2016
Class II · Moderate risk

Estradiol Valerate 20mg/Ml

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

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0983-2016
Class II · Moderate risk

Estradiol Valerate 10mg/Ml

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

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

Estradiol Cypionate 10 Mg/Ml

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

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

Alpha Lipoic Acid 25mg/Ml

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

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

17-0h Progesterone 250mg/Ml

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

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

Potassium CHLORide added to 5% Dextrose Injection

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.

Terminated Labeling / mix-up Pharmedium Services, LLC NDC 61553-836-11 D-0976-2016

Recalls by year