Epinephrine Injection 30 mg/30 mL
American Regent recalls epinephrine 30 mg/30 mL vials due to glass particulates and sterility concerns.
Consumers should immediately check their supply of epinephrine injection for the affected NDC 0517-3030-01 (lot information may be available from the pharmacist or distributor). Stop using the recalled product if present, and contact your pharmacist or healthcare provider for a replacement. For further instructions, contact American Regent at the phone number listed on the recall notice. Return any affected vials to the place of purchase or dispose of them according to your pharmacist's guidance.
Recall at a glance
- Quantity recalled
- 31,935 30mL-vials
Why it was recalled
American Regent is recalling Epinephrine Injection, USP, 30 mg/30 mL multiple-dose vials due to the presence of glass particulate matter and lack of assurance of sterility. Customer complaints reported broken and leaking vials.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Lot code | Best-by | NDC | Distribution |
|---|---|---|---|---|
| – | – | – | – | Beginning |
| Epinephrine Injection, USP | 25128L1C0 | August 2026 | 0517-3030-01 | September 04, 2025 |
| Epinephrine Injection, USP | 25280L1C0 | October 2026 | 0517-3030-01 | December 16, 2025 |
| Epinephrine Injection, USP | 26108L1C0 | July 2027 | 0517-3030-01 | June 15, 2026 |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from American Regent, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-09 · primary source: U.S. Food and Drug Administration