DOBUTamine Injection — Class II drug recall D-0489-2025
Ongoing recall by Pfizer Inc., reported 2025-07-02, distributed nationwide. Discoloration; discolored solution from cracked vials
| Recall number | D-0489-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2025-05-28 |
| Classified | 2025-06-23 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 98,410 vials |
| Reason classes | packaging |
| NDC | 00409-2344, 00409-2344-01, 00409-2344-02, 00409-2344-62 |
| Lot numbers | KA5023 |
| Expiration dates | 2026-02-28 |
Product
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
Reason for recall
Discoloration; discolored solution from cracked vials
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-0489-2025. 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.