Hospira Dopamine HCl Injection
Dopamine HCl injection lacks assurance of sterility.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Pfizer, located in Manhattan, New York, began a recall of 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, on September 4, 2026, due to lack of assurance of sterility. The FDA added the recall to its Enforcement Report and classified it on September 17, 2026, with the product distributed nationwide in the US.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
- NDC
- 0409-5820-11
- 0409-5820-01
- Lot
- NL5230
Details
- Company began the recall
- Sold in
US Nationwide.
- Event ID
- 99824
- Recall No.
- D-0853-2026
- Company
- PfizerManhattan, New York
- Hazard
- Sterility failure
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
