← FDA ENFORCEMENT
D-0503-2026Class II

Wells Pharma of Houston LLC

Recalling firm
Wells Pharma of Houston LLC
Product type
Drug
Status
Ongoing
Report date
2026-05-06
Distribution
U.S. Nationwide.
Firm state
TX
Product quantity
4,030 IV Bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

cGMP deviations.

Product description

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.