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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 2,821–2,840 of 18,047 drug recalls

Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02

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 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02

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 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15

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 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41

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, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75

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 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10

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 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10

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 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01

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

Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02

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 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02

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, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02

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 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15

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 for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41

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 for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41

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 for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41

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

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

by B. Braun Medical Inc

Reason
Subpotent: Low anti-factor IIa Potency.
Recall initiated
May 9, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01

by RemedyRePack Inc.

Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Recall initiated
May 1, 2023
Reported by FDA
May 24, 2023
Distribution
Product was distrituded to three direct account in PA.

View recall →

Drug Recall Ongoing Historical recordClass II

Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;

by RemedyRePack Inc.

Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Recall initiated
May 1, 2023
Reported by FDA
May 24, 2023
Distribution
Product was distrituded to three direct account in PA.

View recall →

Drug Recall Terminated Historical recordClass II

LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00

by RemedyRePack Inc.

Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Recall initiated
May 1, 2023
Reported by FDA
May 24, 2023
Distribution
Product was distrituded to three direct account in PA.

View recall →

Drug Recall Terminated Historical recordClass II

Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.

by Hikma Pharmaceuticals USA Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Recall initiated
May 11, 2023
Reported by FDA
May 24, 2023
Distribution
Nationwide in the USA and Puerto Rico

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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