American Regent Recalls Epinephrine Vials Due to Particulate Matter
American Regent, Inc. is recalling 31,935 vials of Epinephrine Injection due to the presence of particulate matter and broken vials.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
American Regent, Inc. is recalling 31,935 vials of Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL). The recall affects multiple-dose vials intended for intravenous infusion, intramuscular, and subcutaneous use. The product was distributed nationwide within the U.S.A.
The recall was initiated because of the presence of particulate matter and a lack of assurance of sterility. Particulate matter identified in the product includes nylon, cellulosic, acrylic, polyethylene, and glass. Additionally, broken and leaking vials were identified.
The affected lots are 25128L1C0 (Exp. August 31, 2026), 25280L1C0 (Exp. October 31, 2026), and 26108L1C0 (Exp. July 31, 2027). Healthcare providers and patients should stop using the recalled product and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- EPINEPHRINE (EPINEPHRINE)
- Brand
- EPINEPHRINE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lots: 25128L1C0
- Exp. August 31
- 2026
- 25280L1C0
- Exp. October 31
- 26108L1C0
- Exp. July 31
- 2027
Distribution
Distributed nationwide across the United States.
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