Nationwide Epinephrine Recall Tied to Sterility and Particulate Contamination
TL;DR Summary
The FDA announced a nationwide recall of three Epinephrine Injection, USP 30 mg/30 mL multi-dose vials by American Regent due to sterility concerns and particulate contamination (nylon, cellulosic, acrylic, polyethylene, glass). Specific lots 25128L1C0 (Exp Aug 2026), 25280L1C0 (Exp Oct 2026), and 26108L1C0 (Exp July 2027) were distributed nationwide. Patients should stop using recalled product and contact their healthcare provider; distributors and customers will be notified for return or replacement. No adverse events have been reported yet; contact information for questions is provided by American Regent.
- FDA announces nationwide recall of epinephrine injections after reports of cracked vials WESH
- Epinephrine injections recalled. See list of affected products USA Today
- Life Saving Allergy Shots Recalled Nationwide After Cracked Vials, Contamination Concerns NTD News
- Urgent Recall: American Regent Epinephrine Injection Warning The Sun Times News
- American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility Morningstar
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