US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

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

Placebo for Prednisolone Acetate 1%

Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Leiter's Compounding D-0017-2017
Class II · Moderate risk Terminated

Mitomycin 0.02%

Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Leiter's Compounding NDC 70360-005-35 D-0015-2017
Class II · Moderate risk Terminated

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Leiter's Compounding NDC 70360-007-35 D-0012-2017
Class II · Moderate risk Terminated

Brilliant Blue G 0.025% in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Leiter's Compounding NDC 70360-008-35 D-0011-2017
Class II · Moderate risk Terminated

Atropine Sulfate 0.01% in 0.9% Sodium Chloride

Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Leiter's Compounding NDC 70360-011-39 D-0010-2017
Class II · Moderate risk Terminated

Marcaine 0.5%

Reason Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Hospira Inc., A Pfizer Company NDC 0409-1610-50 D-0097-2017
Class II · Moderate risk Terminated

Marcaine 0.25%

Reason Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Hospira Inc., A Pfizer Company NDC 0409-1587-50 D-0096-2017
Class II · Moderate risk Terminated

Desoximetasone Cream USP

Reason Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Taro Pharmaceuticals, Inc. NDC 51672-1271-7 D-0117-2017
Class II · Moderate risk Terminated

Desoximetasone Cream USP

Reason Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Taro Pharmaceuticals, Inc. NDC 51672-1270-7 D-0116-2017
Class II · Moderate risk Terminated

Tri-Mix 18/1/10

Reason Lack of Assurance of Sterility; medication was sterilized with a recalled filter

The Apothecary Shoppe LLC D-0004-2017
Class II · Moderate risk Terminated

Methylcobalamin 5000 mcg/mL Injection

Reason Lack of Assurance of Sterility; medication was sterilized with a recalled filter

The Apothecary Shoppe LLC D-0002-2017
Class II · Moderate risk Terminated

Ondansetron HCI API

Reason Microbial Contamination of Non-Sterile Product

Cadila Pharmaceuticals Limited D-0164-2017
Class II · Moderate risk Terminated

Eye Wash

Reason Lack of assurance of sterility

United Exchange Corporation NDC 0904-6491-20 D-0499-2017
Class II · Moderate risk Terminated

Eye Wash

Reason Lack of assurance of sterility

United Exchange Corporation D-0498-2017
Class II · Moderate risk Terminated

Eye Irrigating Solution

Reason Lack of assurance of sterility

United Exchange Corporation NDC 0536-1083-97 D-0497-2017
Class II · Moderate risk Terminated

Phenylephrine HCI Injection

Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Sandoz Inc NDC 66758-016-03 D-1514-2016
Class II · Moderate risk Terminated

Ephedrine Sulfate Injection

Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Sandoz Inc NDC 66758-008-01 D-1513-2016