Agency classClass IIOur severity:Severe FDA (Drugs)·D-0853-2026·Announced 2026-09-23

Pfizer Recalls Dopamine Hydrochloride Injection Due to Sterility Concerns

Pfizer is recalling specific lots of Dopamine Hydrochloride Injection due to a lack of assurance of sterility. The affected product is distributed nationwide.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a sterile injectable drug with a lack of assurance of sterility falls under the 'Severe' category (Score 4), as it carries a significant risk of serious injury or death if contaminated, even if specific hospitalization reports are not yet detailed in the snippet.

Plain-English summary

Pfizer is recalling Dopamine Hydrochloride Injection, USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose vials. The recall is limited to Lot # NL5230 with an expiration date of 10/2027. The product is distributed by Hospira, Inc., and is available under NDC 0409-5820-11 (vial) and 0409-5820-01 (carton).

The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microbial contamination. The affected units were distributed nationwide in the United States.

Healthcare providers and facilities should stop using the affected lot immediately and contact Pfizer or Hospira for instructions on how to return or dispose of the product. Patients should consult their healthcare provider if they have received this specific medication.

The recalled product

Product: DOPAMINE HYDROCHLORIDE (DOPAMINE HYDROCHLORIDE)
Brand: DOPAMINE HYDROCHLORIDE
Manufacturer: Pfizer
Category: Drug — Injectable
Hazard: sterility
infection

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 # NL5230
Exp Date:10/2027

Distribution

Distributed nationwide across the United States.

Same manufacturer · Pfizer

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