Dobutamine Injection Recall Due to Discoloration and Cracked Vials
Pfizer is recalling one lot of Dobutamine Injection (250 mg/20 mL) nationwide due to discoloration and discolored solution caused by cracked vials. Healthcare facilities should quarantine and return affected units.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths. The hazard is a manufacturing defect (cracked vials and discoloration) that poses a theoretical risk but with no reported adverse health consequences, warranting a Moderate severity rating.
Plain-English summary
Pfizer Inc. is recalling Dobutamine Injection, USP (250 mg/20 mL, 12.5 mg/mL) distributed nationwide in the USA. The recall affects 98,410 vials from Lot KA5023 (expiration 02/28/2026, NDC Carton 0409-2344-02).
The product is being recalled due to discoloration and discolored solution resulting from cracked vials. Dobutamine is an intravenous drug used in healthcare settings. Cracked vials may compromise product integrity and allow contamination.
Hospitals and healthcare facilities that received affected vials should quarantine and stop using them immediately. The product should be returned to the distributor. Healthcare providers with questions should contact Pfizer or their distributor.
The recalled product
- Product
- DOBUTAMINE (DOBUTAMINE)
- Brand
- DOBUTAMINE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Intravenous Injection
- Affected units
- 98,410
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot KA5023
- exp 02/28/2026
Distribution
Distributed nationwide across the United States.
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