Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC has recalled fentanyl citrate injectable solution (1250 mcg/25mL) distributed nationwide due to cGMP deviations. The recall involves 50 syringes from Lot 011226204250063, expiring 05/14/2026.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing practice deviation rather than a direct product contamination or defect with documented harm. Class II recalls are inherently lower risk than Class I but warrant action; this fits the Moderate category.
Plain-English summary
Wells Pharma of Houston LLC is recalling fentanyl citrate injectable solution, a controlled opioid medication, in the strength of 1250 mcg/25mL (50 mcg per mL) in 25 mL vials. The product was distributed nationwide in quantities of 50 syringes. The specific lot affected is Lot 011226204250063 with an expiration date of 05/14/2026 (NDC 73702-204-25).
The recall was initiated by the manufacturer on April 1, 2026, due to current Good Manufacturing Practice (cGMP) deviations. The U.S. Food and Drug Administration classified this recall as Class II on April 28, 2026, and the recall is ongoing as of May 27, 2026.
Healthcare facilities, pharmacies, and other entities that received this product should verify whether they have this lot in stock. Any unused product from this lot should be quarantined and not dispensed. Consult with Wells Pharma of Houston LLC or the FDA for instructions on return or destruction of affected stock.
The recalled product
- Product
- fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
- Manufacturer
- Wells Pharma of Houston LLC
- Hazard
- cGMP-deviation
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 011226204250063
- Exp Date 05/14/2026
Distribution
Distributed nationwide across the United States.