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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 961–980 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.

by Teva Pharmaceuticals USA, Inc

Reason
Presence of foreign tablets/capsules.
Recall initiated
May 23, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

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Drug Recall Completed Historical recordClass I

UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134

by Umary-USA.com

Reason
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Recall initiated
May 21, 2025
Reported by FDA
June 25, 2025
Distribution
U.S. Nationwide via internet.

View recall →

Drug Recall Completed Historical recordClass I

UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295

by Umary-USA.com

Reason
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Recall initiated
May 21, 2025
Reported by FDA
June 25, 2025
Distribution
U.S. Nationwide via internet.

View recall →

Drug Recall Ongoing Historical recordClass II

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25

by Eugia US LLC

Reason
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Recall initiated
May 29, 2025
Reported by FDA
June 25, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

by Aurobindo Pharma USA Inc

Reason
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Recall initiated
May 22, 2025
Reported by FDA
June 25, 2025
Distribution
USA Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Recall initiated
May 30, 2025
Reported by FDA
June 18, 2025
Distribution
IL, PA, & MS

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Drug Recall Ongoing Historical recordClass I

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

by Amneal Pharmaceuticals, LLC

Reason
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Recall initiated
June 2, 2025
Reported by FDA
June 18, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.

by Macleods Pharmaceuticals Ltd

Reason
Presence of a foreign substance: black hair found embedded in tablet.
Recall initiated
May 29, 2025
Reported by FDA
June 18, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Recall initiated
May 23, 2025
Reported by FDA
June 18, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Recall initiated
May 23, 2025
Reported by FDA
June 18, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass I

Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.

by SAINI TRADE INC

Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Recall initiated
April 14, 2025
Reported by FDA
June 18, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.

by SAINI TRADE INC

Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Recall initiated
April 14, 2025
Reported by FDA
June 18, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.

by SAINI TRADE INC

Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Recall initiated
April 14, 2025
Reported by FDA
June 18, 2025
Distribution
Nationwide

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.