FDA · Class II · September 23, 2026

Pfizer recall: Dopamine HCl Inj.

Pfizer is recalling Dopamine HCl Inj. because of a sterility problem – N/A. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on September 4, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

A pharmacy dispensing machine
Illustration: A pharmacy dispensing machine – not the recalled product. Photo: U.S. Air Force / Airman Trevor Calvert, public domain.
ProductDopamine HCl Inj.
BrandPfizer
TypeDrugs
ClassificationClass II
Recall dateSeptember 4, 2026
Published by FDASeptember 23, 2026
QuantityN/A
Recall ID99824
As listed by FDA

Recalled products

  1. Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
    FDA recall number
    D-0853-2026
    Codes, lots and dates
    Lot # NL5230, Exp Date:10/2027
    Quantity
    N/A
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99824
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Manhattan, NY, United States

Why it was recalled

The problem: a sterility problem.

The reason the FDA lists: “Lack of Assurance of Sterility”

Where it was sold

Nationwide. Distribution as the FDA records it: “US Nationwide.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99824, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is Pfizer Dopamine HCl Inj. recalled?

Yes. Pfizer recalled it on September 4, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Because of a sterility problem. The reason given: Lack of Assurance of Sterility

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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