Home/Recalls/FDA-D-0503-2026
FDA DrugsClass II

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per...

Published: May 6, 2026Recall ID: D-0503-2026Category: drugsCountry: US

Reason for Recall / Hazard

cGMP deviations.

Product Description & Identification

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.

Additional Source Details

FieldValue
CityHouston
StateTX
Event id98694
Address 19265 Kirby Dr
Code info120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026
Postal code77054-2520
Report date20260506
Product typeDrugs
Product quantity4,030 IV Bags
Reason for recallcGMP deviations.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260401
Initial firm notificationLetter
Center classification date20260428

Overview

  • Recalling FirmWells Pharma of Houston LLC
  • StatusOngoing
  • Risk LevelClass II
  • DistributionU.S. Nationwide.
Official Agency Alert