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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 3,061–3,080 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.

by McGuff Compounding Pharmacy Services, Inc.

Reason
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Recall initiated
December 8, 2022
Reported by FDA
February 22, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.

by McGuff Compounding Pharmacy Services, Inc.

Reason
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Recall initiated
December 8, 2022
Reported by FDA
February 22, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.

by BIOCON PHARMA INC

Reason
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Recall initiated
January 31, 2023
Reported by FDA
February 15, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02

by Akorn, Inc.

Reason
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Recall initiated
January 30, 2023
Reported by FDA
February 15, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.

by Urban Electric Power

Reason
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Recall initiated
January 17, 2023
Reported by FDA
February 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles

by Urban Electric Power

Reason
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Recall initiated
January 17, 2023
Reported by FDA
February 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Recall initiated
January 13, 2023
Reported by FDA
February 8, 2023
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland

by DISCOVERY PHARMA LLC

Reason
CGMP deviations
Recall initiated
November 9, 2022
Reported by FDA
February 8, 2023
Distribution
CA, FL, WA

View recall →

Drug Recall Terminated Historical recordClass II

Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR

by Frenda Corporation

Reason
cGMP Deviations
Recall initiated
December 15, 2022
Reported by FDA
February 8, 2023
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2

by Frenda Corporation

Reason
cGMP Deviations
Recall initiated
December 15, 2022
Reported by FDA
February 8, 2023
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976

by Frenda Corporation

Reason
cGMP Deviations
Recall initiated
December 15, 2022
Reported by FDA
February 8, 2023
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976

by Frenda Corporation

Reason
cGMP Deviations
Recall initiated
December 15, 2022
Reported by FDA
February 8, 2023
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7

by Frenda Corporation

Reason
cGMP Deviations
Recall initiated
December 15, 2022
Reported by FDA
February 8, 2023
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3

by Frenda Corporation

Reason
cGMP Deviations
Recall initiated
December 15, 2022
Reported by FDA
February 8, 2023
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9

by Frenda Corporation

Reason
cGMP Deviations
Recall initiated
December 15, 2022
Reported by FDA
February 8, 2023
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131

by GFA Production Xiamen Co. Ltd.

Reason
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Recall initiated
December 23, 2022
Reported by FDA
February 8, 2023
Distribution
Nationwide and Canada.

View recall →

Drug Recall Terminated Historical recordClass I

CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700

by GFA Production Xiamen Co. Ltd.

Reason
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Recall initiated
December 23, 2022
Reported by FDA
February 8, 2023
Distribution
Nationwide and Canada.

View recall →

Drug Recall Terminated Historical recordClass I

Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132

by GFA Production Xiamen Co. Ltd.

Reason
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Recall initiated
December 23, 2022
Reported by FDA
February 8, 2023
Distribution
Nationwide and Canada.

View recall →

Drug Recall Terminated Historical recordClass I

Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150

by GFA Production Xiamen Co. Ltd.

Reason
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Recall initiated
December 23, 2022
Reported by FDA
February 8, 2023
Distribution
Nationwide and Canada.

View recall →

Drug Recall Terminated Historical recordClass I

Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2128

by GFA Production Xiamen Co. Ltd.

Reason
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Recall initiated
December 23, 2022
Reported by FDA
February 8, 2023
Distribution
Nationwide and Canada.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.