Dopamine Hydrochloride Injection Recalled Due to Lack of Sterility Assurance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for dopamine hydrochloride injection, USP, 40 mg/mL. The affected batch has been identified as Lot NL5230 (expiring October 2027).
• The recall was initiated by Pfizer due to a lack of sterility assurance, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Dopamine hydrochloride injection is used to treat shock and low blood pressure.

The FDA has issued a Class II recall for dopamine hydrochloride injection, USP, 40 mg/mL. This product is being recalled by Pfizer based in Manhattan, New York. The recall was initiated on September 4, 2026, and received a Class II classification on September 17, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product’s lack of sterility assurance. The affected product is Lot NL5230, which will expire in October 2027. Pfizer has sent out a public notice via letter; no press release has been issued for this recall.

Dopamine hydrochloride injection is used to treat shock and low blood pressure. Pharmacists should identify and quarantine Lot NL5230, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 23, 2026. Accessed September 24, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222555