FDA-Drug2026-09-23Class IIPROCESSING DEFECT
Pfizer Dopamine HCl injection recalled for lack of sterility assurance
What this means
Pfizer has recalled one lot of Dopamine HCl injection (40 mg/mL) distributed nationwide due to a lack of assurance of sterility. The affected lot is NL5230, with an expiration date of October 2027. This is a precautionary measure to ensure patient safety.
- Check your facility's dopamine stock for lot number NL5230.
- Do not use vials from this lot.
- Contact Pfizer or your supplier for return or replacement instructions.
- Report any adverse events to the FDA MedWatch program.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
66 Hudson Blvd, N/A, Manhattan, NY, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0853-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.