Home/Recalls/FDA-D-0504-2026
FDA DrugsClass II

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mc...

Published: May 6, 2026Recall ID: D-0504-2026Category: drugsCountry: US

Reason for Recall / Hazard

cGMP deviations.

Product Description & Identification

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.

Additional Source Details

FieldValue
CityHouston
StateTX
Event id98694
Address 19265 Kirby Dr
Code info120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/06/2026, 02182202030398, Exp Date 06/20/2026.
Postal code77054-2520
Report date20260506
Product typeDrugs
Product quantity2940 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