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Home › FDA recalls › fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
CLASS II · ModerateFDA

Wells Pharma of Houston LLC recalls fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride

📅 Apr 1, 2026 · 📍 Nationwide
Recalling company
Wells Pharma of Houston LLC
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
cGMP deviations.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 1, 2026
Reported
May 6, 2026
Distribution
U.S. Nationwide.
Status
Ongoing
Quantity
2940 IV Bags
Lot / codes
120125202032701, 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.
Company location
Houston, TX
Recall type
Voluntary: Firm initiated
Recall number
D-0504-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0504-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.