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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 1,101–1,120 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

by Fresenius Medical Care Holdings, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 27, 2025
Reported by FDA
July 2, 2025
Distribution
Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62

by Pfizer Inc.

Reason
Discoloration; discolored solution from cracked vials
Recall initiated
May 28, 2025
Reported by FDA
July 2, 2025
Distribution
Nationwide in the USA

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

Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), 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

Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/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

Tirzepatide Injections, 30mg/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

Tirzepatide Injections, 20mg/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

Tirzepatide Injections, 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

Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/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, 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

View recall →

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

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.

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