FDA Drug recall D-0489-2025
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…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of 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… by Pfizer, citing discoloration; discolored solution from cracked vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0489-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-28 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
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
Discoloration; discolored solution from cracked vials
Identifiers
| ndc | 0409-2344-01 |
|---|---|
| ndc | 0409-2344-62 |
| ndc | 0409-2344-02 |
| code_info | Lot KA5023, exp 02/28/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0489-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.