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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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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.

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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.

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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

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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

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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

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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

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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

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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

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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.

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Drug Recall Ongoing Historical recordClass II

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28

by AvKARE

Reason: Failed Content Uniformity Specifications
Recall initiated: September 2, 2025
Reported by FDA: October 15, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

by ACCORD HEALTHCARE, INC.

Reason: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Recall initiated: September 16, 2025
Reported by FDA: October 15, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.

by Acuity Specialty Products, Inc.

Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Recall initiated: September 29, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.

by Acuity Specialty Products, Inc.

Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Recall initiated: September 29, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Terminated Historical recordClass II

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

by RC Outsourcing, LLC

Reason: Lack of assurance of sterility.
Recall initiated: September 22, 2025
Reported by FDA: October 15, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.

by Apotex Corp.

Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Recall initiated: September 5, 2025
Reported by FDA: October 8, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).

by Apotex Corp.

Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Recall initiated: September 5, 2025
Reported by FDA: October 8, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

by Amerisource Health Services LLC

Reason: Failed Dissolution Specifications.
Recall initiated: September 15, 2025
Reported by FDA: October 8, 2025
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Recall initiated: September 24, 2025
Reported by FDA: October 8, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Recall initiated: September 24, 2025
Reported by FDA: October 8, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25

by Medline Industries, LP

Reason: Subpotent drug
Recall initiated: August 19, 2025
Reported by FDA: October 1, 2025
Distribution: Nationwide in the USA

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Data last updated: October 30, 2026 ET

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.