FDA recall D-0503-2026

Wells Pharma of Houston LLC · Class II · drug

Product

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

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-0503-2026