FDA recall D-0504-2026

Wells Pharma of Houston LLC · Class II · drug

Product

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

Reason for recall

cGMP deviations.

Distribution

U.S. Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-04-01
Report date
2026-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0504-2026