Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.
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: The recall is FDA Class II and is voluntary and firm-initiated. No reported illnesses, injuries, or hospitalization are mentioned in the source text. The hazard cited is a manufacturing practice deviation rather than a direct health threat, making this a precautionary recall typical of Class II severity.
Plain-English summary
Wells Pharma of Houston LLC is voluntarily recalling fentanyl citrate injectable solution in 0.9% sodium chloride (50 mcg/5mL, 10 mcg per mL, NDC 73702-202-15) distributed nationwide in the United States.
The recall was initiated on April 1, 2026, due to cGMP (current Good Manufacturing Practice) deviations. The affected product is Lot 020226202150202 with an expiration date of May 5, 2026, comprised of 50 syringes.
Patients and healthcare providers in possession of this product should stop using it and contact Wells Pharma of Houston LLC or their local pharmacy for instructions on return or disposal. Prescribers and pharmacists are advised to check their inventory for the affected lot number and notify patients who may have received doses from this batch.
The recalled product
- Product
- fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
- Manufacturer
- Wells Pharma of Houston LLC
- Category
- Drug — Injectable Solution
- Hazard
- manufacturing-deviation
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 020226202150202
- Exp Date 05/05/2026.
Distribution
Distributed nationwide across the United States.