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.

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| Product | Dopamine HCl Inj. |
| Brand | Pfizer |
| Type | Drugs |
| Classification | Class II |
| Recall date | September 4, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | N/A |
| Recall ID | 99824 |
Recalled products
- 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
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.
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Failed Dissolution Specifications: below specification Serious | FDA Class II | |
| Oct 7, 2026 | Crystallization Serious | FDA Class II | |
| Oct 7, 2026 | Failed dissolution specifications. Serious | FDA Class II | |
| Oct 7, 2026 | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II | |
| Oct 7, 2026 | a sterility problem Serious | FDA Class II | |
| Oct 7, 2026 | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
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.
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.