Class II · Moderate risk
Dobutamine
Lack of sterility assurance
DOBUTamine Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Discoloration; discolored solution from cracked vials
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDCs
0409-2344-02
0409-2344-62
Compare with the code on your package — it is the most precise check available.
Drug: Dobutamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dobutamine NDC 00409-2344 |
HYDROCHLORIDE 12.5 mg/mL | Injection, Solution, Concentrate Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Pfizer Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0489-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Dobutamine recalls
See all
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk
Dobutamine 2000 mcg/mL in a) D5W-500 mL
Lack of Sterility Assurance.
Class II · Moderate risk
DOBUTAMINE HCL in D5W
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Dobutamine various strengths in dextrose
Lack of sterility assurance.
Other recalls by Pfizer Inc.
All 2025 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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