Wells Pharma Of Houston Llc: Fentanyl Citrate Injectable Solution, Narcotic, Cii, 1250 Mcg/25ml (50 Mcg Per Ml)

Wells Pharma of Houston LLC is recalling fentanyl citrate injectable solution (50 mcg per mL vials) nationwide due to manufacturing process deviations that don't meet required standards. This is a Class II recall, meaning the product could cause adverse health effects. The recalled product was distributed across all U.S. states and the District of Columbia.

Recalling firm
Wells Pharma of Houston LLC
Product
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Reason
cGMP deviations.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-01
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
U.S. Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/65f52727-c237-4a71-9c58-15103d994443