Recall summary Issued September 03, 2026
- Product
- Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
- Brand
- American Regent, Inc.
- Reason
- Presence of particulate matter (identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass) and lack of sterility assurance. The recall was initiated following customer complaints for leaking and cracked vials, and a subsequent firm investigation. No reports of adverse events have been received to date.
Recommended action (Source: FDA)
Stop using the recalled epinephrine injection vials immediately and check for signs of leaking or cracking. Stop using it and ask the store where you bought it about a refund. If you have concerns about potential injury or lack of sterility, contact your healthcare provider.
| Barcode (UPC) | Expiry date | Lot code |
|---|---|---|
| 10305173030012 | August 2026, October 2026, July 2027 | 25128L1C0, 25280L1C0, 26108L1C0 |
Company contact information
American Regent, Inc. Customer Service
8:00AM-6:00PM EST, Monday – Thursday, 8:00AM- 4:00PM EST, Friday