“Pfizer recalls DOBUTamine injection vials with discoloration risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32047-pfizer-recalls-dobutamine-injection-vials-with-discoloration-risk. Based on FDA recall #D-0489-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0489-2025%22&limit=1).
Pfizer Inc. recalled DOBUTamine Injection, USP due to discoloration from cracked vials, the FDA said on May 28, 2025. The voluntary Class II recall affects 98,410 vials distributed nationwide.
How to tell if you have it
Brand: Pfizer
Product: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials
NDC Carton: 0409-2344-02
NDC Vial: 0409-2344-62
Lot code: KA5023
Expiration date: 02/28/2026
The hazard
The recall addresses discolored solution resulting from cracked vials. The FDA classified the recall as Class II.
Context
GovInfoNow's records show Pfizer Inc. has issued 71 other recalls since November 26, 2012. Recent Pfizer recalls include a Sodium Bicarbonate Injection recall on August 4, 2025, for lack of sterility assurance, and a Bicillin L-A Injectable Suspension recall on July 10, 2025, involving particulate risk. Other recent recalls of similar products include a Dopamine HCl Inj Recall by Pfizer on September 4, 2026, a PEMRYDI RTU recall by Shilpa Medicare on July 29, 2026, for green discoloration risk, and a Methohexital Sodium Recall by OneSource Specialty Pharma on June 7, 2026, for impurities risk.
How to tell if you have this one
Check for discoloration in the vial. The product is a 20 mL single-dose vial in a carton of 10, labeled 'DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL)'.
Brand
Pfizer
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Condition
Inspect the vial for discoloration or cracks. If present, do not use the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0489-2025 (May 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0489-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.