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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 741–760 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

GAC 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

Calcium 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

Biotin 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

B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.

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

Bacteriostatic Water 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, Extension Health and Medical Health Institute

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

B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness

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

B5 Dexpanthenol 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

B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.

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

B12 Hydroxocobalamin 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

Ascorbic Acid (Vitamin C) for Injection, Preserved, 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

Ascorbic Acid (Vitamin C) for Injection, Preservative Free, 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

Amino Blend 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

Alpha Lipoic Acid 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

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.

by Acella Pharmaceuticals, LLC

Reason
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Recall initiated
September 29, 2025
Reported by FDA
October 15, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Recall initiated
September 12, 2025
Reported by FDA
October 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Recall initiated
September 12, 2025
Reported by FDA
October 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Recall initiated
September 12, 2025
Reported by FDA
October 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Recall initiated
September 12, 2025
Reported by FDA
October 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Recall initiated
September 12, 2025
Reported by FDA
October 15, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25

by Dr. Reddy's Laboratories, Inc.

Reason
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Recall initiated
September 26, 2025
Reported by FDA
October 15, 2025
Distribution
Nationwide within 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.