Hospira Recalls Dobutamine Injection Vials Due to Discoloration and Particulates
Hospira Inc. is recalling 24,000 vials of Dobutamine Injection due to reports of product discoloration and particulates. The affected lot was distributed nationwide and to Puerto Rico and the Bahamas.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for temporary or medically reversible adverse health consequences, or where proper labeling is required, are typically scored as Severe (4), especially given the presence of particulates in an IV product.
Plain-English summary
Hospira Inc. is recalling 24,000 vials of DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only. The recall is being conducted because the firm received complaints regarding product discoloration and particulates.
The affected product is identified by Lot # 52175DD with an expiration date of 01 Oct 2016. The NDC number is 0409-2025-20. According to the recall notice, 23,700 units were distributed to the US and Puerto Rico, and 300 units were distributed to the Bahamas. Additionally, 30 units were returned by a customer and destroyed internally.
This recall is classified as FDA Class II. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be quarantined and not used. The firm is responsible for managing the recall and handling any returns.
The recalled product
- Product
- DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Affected units
- 24,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 52175DD
- Exp 01 Oct 2016
Distribution
Related recalls
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · contamination
See all →- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02