American Regent epinephrine injection recalled for particulate matter and sterility concerns
What this means
American Regent is recalling three lots of epinephrine injection (1 mg/mL multi-dose vials) due to leaking and cracked vials, plus contamination with particles including nylon, cellulosic, acrylic, polyethylene, and glass. These particles can block blood vessels, cause blood clots, and damage organs; cracked vials also risk loss of sterility and bacterial contamination. No adverse events have been reported so far.
- If you have one of the three affected lots (25128L1C0, 25280L1C0, or 26108L1C0), stop using it immediately.
- Healthcare facilities and distributors should stop using and return or discard recalled vials.
- Contact your doctor or pharmacist if you have used this product and have concerns.
- Report any problems to American Regent at 888-354-4855 or pqc@americanregent.com, or to FDA MedWatch at www.fda.gov/medwatch.
Product photos
The agency's original wording
FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, re
Official notice
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30More American Regent recalls
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