Drug & medication recalls Moderate risk

FentaNYL Citrate Injectable Solution recalled over manufacturing violations

Recall date
April 1, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Wells Pharma of Houston LLC recalls fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houst…
Recall number
D-0503-2026
FDA classification
Class II
Brand / firm
Wells Pharma of Houston LLC
Sold / distributed
U.S. Nationwide.

Why it was recalled

cGMP deviations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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