CLASS II ONGOING Drug recall · Reported 2 Jul 2025 · FDA Enforcement Report
DOBUTamine Injection, USP, 250 mg recalled by Pfizer
Pfizer is recalling DOBUTamine Injection, USP, 250 mg/ (12.5 mg/mL) per Single-dose Vial, carton of 10, distributed nationwide in the US. The recall was initiated on 28 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0489-2025
- FDA event ID
- 96947
- Recalling firm
- Pfizer, New York, NY
- Brand
- Dobutamine
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2025
- FDA classified
- 23 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 28 May 2025 | Recall initiated by company | |
| 23 Jun 2025 | Classified by FDA | +26 days |
| 2 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration; discolored solution from cracked vials
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Discoloration; discolored solution from cracked vials
Which lots are affected?
Lot KA5023, exp 02/28/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pfizer
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Dobutamine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dobutamine, (a) 1080MG IN D5W, (b) 760MG IN D5W, ionotrop recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only recalled | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Dobutamine 2000 mcg/mL in a) D5W-, b) D5W-, c) D5W recalled | Baptist Health Medical Towers Pharmacy and Infusion Services | Sterility | AR |
| Drug | CLASS II | Dobutamine HCL in D5W, Packaged as a) 240MG in Homepumps recalled | Sentara Enterprises | Sterility | NC, VA |
| Drug | CLASS I | DOBUTamine Injection, USP, 250 mg per Single-dose Fliptop Vial recalledDobutamine | Hospira | Particulate Matter | Nationwide |