CLASS II ONGOING Drug recall · Reported 23 Sep 2026 · FDA Enforcement Report
Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalled
Pfizer is recalling Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose, 25 vials per tray, distributed nationwide in the US. The recall was initiated on 4 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0853-2026
- FDA event ID
- 99824
- Recalling firm
- Pfizer, Manhattan, NY
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Sep 2026
- FDA classified
- 17 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Sep 2026 | Recall initiated by company | |
| 17 Sep 2026 | Classified by FDA | +13 days |
| 23 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # NL5230, Exp Date:10/2027
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Dopamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg recalledDopamine Hydrochloride And Dextrose | Baxter Healthcare | Sterility | Nationwide |