May 2025 FDA Recall Dobutamine by Pfizer Inc.
D-0489-2025 - Discoloration; discolored solution from cracked vials
This Class II drug recall was voluntarily initiated by Pfizer Inc. on May 28, 2025 for the product Dobutamine. The FDA reported the reason for recall as discoloration; discolored solution from cracked vials. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0489-2025
Discoloration; discolored solution from cracked vials
05-28-2025
07-02-2025
98,410 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot KA5023, exp 02/28/2026
