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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 841–860 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
September 19, 2025
Reported by FDA
October 22, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
September 19, 2025
Reported by FDA
October 22, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
September 19, 2025
Reported by FDA
October 22, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.

by VIONA PHARMACEUTICALS INC

Reason
Discoloration
Recall initiated
October 6, 2025
Reported by FDA
October 22, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass I

Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1

by IntegraDose Compounding Services LLC

Reason
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Recall initiated
September 16, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Microbial Contamination of Sterile Products: elevated endotoxin levels
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US 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.

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