FentaNYL Citrate injectable Solution in 0 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 in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag,…

Recall number

D-0504-2026

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 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.