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Epinephrine

FDA recalls

9 rows

DateCompany and reasonClass
Aug 10, 2026American Regent, Inc.
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class I · Ongoing
May 13, 2026Fresenius Kabi USA, LLC
Failed Impurities/Degradations Specifications
Class III · Ongoing
Mar 31, 2026International Medication Systems Ltd.
Lack of Assurance of Sterility
Class II · Ongoing
Jan 16, 2024Henry Schein Inc. and Glove Club Hsi Gloves Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class II · Completed
Mar 15, 2023Focus Health Group Inc
Labeling; Incorrect NDC number on outer carton of product.
Class III · Ongoing
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Class II · Terminated
Mar 14, 2021Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Terminated
Mar 4, 2020Teva Pharmaceuticals USA
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Class II · Terminated
Mar 11, 2017Meridian Medical Technologies A Pfizer Company
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class I · Ongoing

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).