Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
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FDA Drug Recalls

11,818 recalls · Class II, 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

DHEA 10 mg SR Caps

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.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1019-2015
Class II · Moderate risk

Voriconazole 1% Opth Drops

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.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1018-2015
Class II · Moderate risk

Acetylcysteine 10% Opth Solution

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.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1017-2015
Class II · Moderate risk

Ibuprofen 10% cream

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.

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

Naltrexone 4.5 mg Caps

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.

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

Estriol 5% Cream Vaginal Cream

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.

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

Estradiol 0.01% Vaginal Cream

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.

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

Testosterone 100 mg/1 mL Injection

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.

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

Progest 200 mg/1 mL Cream

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.

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

Phospholine Iodide 0.03% Opth Drops

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.

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

Serum 50% BSS 50% Opth Drops

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.

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

EDTA 3% Eye Drops

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.

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

Glycerin 98.5% Opth. Solution

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.

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

Fortifed Tobramycin 15 mg/1 mL Opth.

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.

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

Dexamethasone 4 mg/mL Iontophoresis

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.

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

Trimix #1 (Original)

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.

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

Laureth-P 1% Injection

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.

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

Sodium Tetradecyl 1% Injection

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.

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

Methylcobalamin 1000 mcg/mL Injection

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.

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

Cyanocobalamin 2000mcg/1ml Injection

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.

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

HCG 1000 Units/mL Injection

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.

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

17-HP Hydroxyprogesterone 250mg/1ml Injection

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.

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

Mafenide Acetate

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

Terminated Particulate / foreign matter Par Pharmaceutical Inc. NDC 49884-902-52 D-0393-2015

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