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-0503-2026
- Brand
- Wells Pharma of Houston
- Classification
- Class II
- Units affected
- 4,030 IV Bags
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
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.
Affected products
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
- 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
- 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.
Report a data error on this page