US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 15, 2016 (10 years ago)

DOBUTamine Injection

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Discoloration: Firm received complaints of product discoloration and particulates.

What was recalled

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

Recalling firm
Hospira Inc.
NDC code
0409-2025-20
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1500-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Dobutamine recalls

See all
Class II · Moderate risk Ongoing

DOBUTamine Injection

Reason Discoloration; discolored solution from cracked vials

Pfizer Inc. D-0489-2025
Class II · Moderate risk Terminated

Dobutamine

Reason Lack of sterility assurance

Sentara Infusion Services D-0290-2023
Class II · Moderate risk Terminated

Dobutamine 2000 mcg/mL in a) D5W-500 mL

Reason Lack of Sterility Assurance.

Baptist Health Medical Towers Pharmacy and Infusion Services D-0925-2016
Class II · Moderate risk Terminated

DOBUTAMINE HCL in D5W

Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Sentara Enterprises D-0622-2016