Vial Label: Epinephrine Injection — Class II drug recall D-0590-2025
Ongoing recall by PFIZER INC, reported 2025-08-27, distributed nationwide. Lack of Assurance of Sterility.
| Recall number | D-0590-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PFIZER INC, New York, NY, United States |
| Recall initiated | 2025-08-04 |
| Classified | 2025-08-18 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 49,620 vials |
| Reason classes | sterility |
| NDC | 00409-4933-05, 00409-4933-10 |
| Lot numbers | LY3681, LY4360, LY4416 |
| Expiration dates | 2026-02-28 |
Product
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Reason for recall
Lack of Assurance of Sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0590-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.