FDA Recall D-0505-2026
Wells Pharma of Houston LLC · Houston, TX
Class II Ongoing 43 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Reason for recall
cGMP deviations.
Recall record
- Recall number
D-0505-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide.
- Recall initiated
- 2026-04-01
- Classified by FDA Center
- 2026-04-28
- FDA published
- 2026-05-06
- Recalling firm
- Wells Pharma of Houston LLC
- Firm location
- Houston, TX
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.