FDA Recall D-0489-2025

Pfizer Inc. · New York, NY

Class II Ongoing 351 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot KA5023, exp 02/28/2026

Quantity: 98,410 vials

Reason for recall

Discoloration; discolored solution from cracked vials

Recall record

Recall number: D-0489-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-05-28
Classified by FDA Center: 2025-06-23
FDA published: 2025-07-02
Recalling firm: Pfizer Inc.
Firm location: New York, NY

Drug identification

Brand name(s): DOBUTAMINE
Generic name(s): DOBUTAMINE
Manufacturer(s): Hospira, Inc.
NDC(s): 0409-2344
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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