FDAClass II · Drug · Recalled May 6, 2026

fentaNYL Citrate Injectable Solution recall — Wells Pharma of Houston LLC

Hazard: cGMP deviations.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0505-2026
Brand: Wells Pharma of Houston
Classification: Class II
Units affected: 50 syringes
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

Affected products

fentaNYL Citrate Injectable Solution

Companies & origin

Recalling firm location: Houston, TX, United States
Firm address: 9265 Kirby Dr, 77054-2520

Identifying details (verbatim from the notice)

Product codes / lots: Lot 011226204250063, Exp Date 05/14/2026
Distribution: U.S. Nationwide.
Firm notified the public via: Letter
FDA event ID: 98694
Recall initiated: April 1, 2026
FDA classified: April 28, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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