Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 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 cGMP deviations. The source text does not report any illnesses, injuries, or adverse health events. The hazard is manufacturing-process related rather than a direct safety threat, and no reported harm makes this a precautionary recall. Per the rubric, Class II with no reported illness/injury and no specific safety hazard (not allergen, high-risk pathogen, or structural defect) is typically Moderate.
Plain-English summary
Wells Pharma of Houston LLC is voluntarily recalling fentanyl citrate injectable solution, a narcotic controlled substance (DEA Schedule II), in 100 mL IV bags at a concentration of 1000 mcg/100 mL (10 mcg per mL). The product is identified by NDC 73702-202-02 and manufactured by Wells Pharma in Houston. This recall affects approximately 4,030 IV bags that were distributed nationwide.
The recall was initiated due to current good manufacturing practice (cGMP) deviations discovered at the manufacturing facility. The FDA classified this as a Class II recall. Wells Pharma initiated the recall voluntarily after notifying the FDA by letter on April 1, 2026, with the FDA center classification occurring on April 28, 2026.
The affected product includes multiple lot numbers with expiration dates ranging from April 9, 2026 to June 24, 2026. Specific lot codes include 120925202022769, 123125202022883, 123125202022884, 011226202020057, 011226202020058, 011626202020110, 012726202020156, 012726202020161, 020226202020195, 021826202020386, 022026202020417, and 022026202020424.
Healthcare providers and patients with this product should stop using it and contact Wells Pharma or their supplier for instructions on return or destruction. Patients should not abruptly discontinue fentanyl; they should consult their healthcare provider immediately for alternative pain management options.
The recalled product
- Product
- 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.
- 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 (15)
- 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
- 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
Distributed nationwide across the United States.