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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 2,741–2,760 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41

by Astral SteriTech Private Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
May 15, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05

by Sanofi-Aventis U.S. LLC

Reason
Lack of Assurance of Sterility: Malformed crimped collar seal
Recall initiated
April 11, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61

by The Harvard Drug Group

Reason
Product mixup: one foreign tablet found in product.
Recall initiated
April 24, 2023
Reported by FDA
May 17, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6

by Apotex Corp.

Reason
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Recall initiated
April 26, 2023
Reported by FDA
May 17, 2023
Distribution
Nationwide throughout the United States

View recall →

Drug Recall Ongoing Historical recordClass I

Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.

by Camber Pharmaceuticals Inc.

Reason
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Recall initiated
March 13, 2023
Reported by FDA
May 17, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

by Gadget Island, Inc

Reason
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated
April 26, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass I

NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.

by Gadget Island, Inc

Reason
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated
April 26, 2023
Reported by FDA
May 10, 2023
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.