FDA Recall D-0503-2026

Wells Pharma of Houston LLC · Houston, TX

Class II Ongoing 43 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 120925202022769, 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

Quantity: 4,030 IV Bags

Reason for recall

cGMP deviations.

Recall record

Recall number: D-0503-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide.
Recall initiated: 2026-04-01
Classified by FDA Center: 2026-04-28
FDA published: 2026-05-06
Recalling firm: Wells Pharma of Houston LLC
Firm location: Houston, TX

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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