DOBUTamine Injection recall
FDA recall D-0489-2025 · initiated May 28, 2025
Pfizer Inc. recalled DOBUTamine Injection in May 2025 — an FDA Class II recall (D-0489-2025) because Discoloration; discolored solution from cracked vials.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discoloration; discolored solution from cracked vials
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 98,410 vials
Details
- Product
- 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
- Recalling company
- Pfizer Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 28, 2025
- FDA report date
- Jul 2, 2025
Frequently asked
- Was DOBUTamine Injection recalled?
- Pfizer Inc. recalled DOBUTamine Injection in May 2025 — an FDA Class II recall (D-0489-2025) because Discoloration; discolored solution from cracked vials. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was DOBUTamine Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0489-2025 was: Discoloration; discolored solution from cracked vials
- Is a recalled DOBUTamine Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of DOBUTamine Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot KA5023, exp 02/28/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0489-2025.