Dobutamine Injection, Solution, Concentrate
FDA Recall NDC 0409-2344
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Dobutamine (NDC 0409-2344). A significant event, classified as Class II, was initiated on May 28, 2025 by Hospira, Inc.. The reported reason for this action was: "Discoloration; discolored solution from cracked vials"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
May 2025 Class II Recall: Discoloration; discolored solution from cracked vials
Recall Number
Class II Ongoing
Discoloration; discolored solution from cracked vials
May 28, 2025
Jul 02, 2025
98,410 vials
Recall Profile & Regulatory Data
Event ID
96947
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Affected Packages Involved in this Recall
0409-2344-01Product
0409-2344-62Product
0409-2344-02Product
Class I Terminated
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Jan 10, 2014
Aug 27, 2014
123,900 vials
Recall Profile & Regulatory Data
Event ID
67354
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Jul 14, 2015
Product Description
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
Batch or Lot Expiration Information
Lot# 27-352-DK; Exp 03/15
Affected Packages Involved in this Recall
0409-2344-01Product
0409-2344-62Product
0409-2344-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
