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

Ibuprofen 10% cream

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1016-2015
Class II · Moderate risk Terminated

Naltrexone 4.5 mg Caps

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1015-2015
Class II · Moderate risk Terminated

Estriol 5% Cream Vaginal Cream

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1014-2015
Class II · Moderate risk Terminated

Estradiol 0.01% Vaginal Cream

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1013-2015
Class II · Moderate risk Terminated

Testosterone 100 mg/1 mL Injection

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1012-2015
Class II · Moderate risk Terminated

Progest 200 mg/1 mL Cream

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1011-2015
Class II · Moderate risk Terminated

Phospholine Iodide 0.03% Opth Drops

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1010-2015
Class II · Moderate risk Terminated

Serum 50% BSS 50% Opth Drops

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1009-2015
Class II · Moderate risk Terminated

EDTA 3% Eye Drops

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1008-2015
Class II · Moderate risk Terminated

Glycerin 98.5% Opth. Solution

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1007-2015
Class II · Moderate risk Terminated

Fortifed Tobramycin 15 mg/1 mL Opth.

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1006-2015
Class II · Moderate risk Terminated

Dexamethasone 4 mg/mL Iontophoresis

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1005-2015
Class II · Moderate risk Terminated

Trimix #1

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1004-2015
Class II · Moderate risk Terminated

Laureth-P 1% Injection

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1003-2015
Class II · Moderate risk Terminated

Sodium Tetradecyl 1% Injection

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1002-2015
Class II · Moderate risk Terminated

Methylcobalamin 1000 mcg/mL Injection

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1001-2015
Class II · Moderate risk Terminated

Cyanocobalamin 2000mcg/1ml Injection

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1000-2015
Class II · Moderate risk Terminated

HCG 1000 Units/mL Injection

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-0999-2015
Class II · Moderate risk Terminated

17-HP Hydroxyprogesterone 250mg/1ml Injection

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-0998-2015
Class II · Moderate risk Terminated

Mafenide Acetate

Reason Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene

Par Pharmaceutical Inc. NDC 49884-902-52 D-0393-2015
Class II · Moderate risk Terminated

Antacid Liquid Regular Strength Antacid & Anti-Gas

Reason Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.

Tarmac Products, Inc. NDC 0363-0073-02 D-0419-2015
Class II · Moderate risk Terminated

Erythromycin Pledgets USP

Reason Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.

Akorn, Inc. NDC 61748-202-60 D-0385-2015