# FDA recall D-0489-2025

> **Pfizer Inc.** · Class II · drug recall initiated 2025-05-28.

## 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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0489-2025
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-28
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2025

## Citation

> AI Analytics. FDA recall D-0489-2025. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0489-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*