Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard is a manufacturing practice deviation rather than a direct contamination or safety failure. Per the rubric, Class II recalls without hospitalization or injury reports typically fall at severity 2 or 3; the absence of any reported adverse events and the nature of the violation (cGMP deviations, not confirmed product defect or contamination) support a Moderate classification.
Plain-English summary
Wells Pharma of Houston LLC is voluntarily recalling fentanyl citrate injectable solution in 0.9% sodium chloride (2500 mcg/250 mL, 10 mcg per mL) in 250 mL bags due to cGMP deviations. The affected product is identified by NDC 73702-202-03, with approximately 2,940 IV bags involved.
The recalled lots and expiration dates include: 120125202032701 (04/01/2026), 122625202032857 (04/25/2026), 122625202032862 (04/28/2026), 122625202032863 (04/28/2026), 122625202032864 (04/28/2026), 122625202032865 (04/28/2026), 011226202030062 (05/14/2026), 011326202030776 (05/15/2026), 011326202030077 (05/15/2026), 011626202030111 (05/20/2026), 011926202030122 (05/21/2026), 011926202030123 (05/21/2026), 012726202030159 (05/28/2026), 020226202030200 (06/04/2026), 020326202030216 (06/05/2026), 020426202030234 (06/06/2026), and 02182202030398 (06/20/2026). The product was distributed nationwide.
The firm initiated the recall on April 1, 2026, with notification to customers by letter. The FDA classified this as a Class II recall on April 28, 2026. Patients or healthcare providers in possession of affected lots should stop using the product and contact Wells Pharma of Houston or their healthcare provider.
The recalled product
- Product
- fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
- Manufacturer
- Wells Pharma of Houston LLC
- Category
- Drug — Injectable Narcotic
- Hazard
- Affected units
- 2,940
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 (20)
- 120125202032701
- Exp Date 04/01/2026
- 122625202032857
- Exp Date 04/25/2026
- 122625202032862
- Exp Date 04/28/2026
- 122625202032863. Exp Date 04/28/2026
- 122625202032864
- 122625202032865
- 011226202030062
- Exp Date 05/14/2026
- 011326202030776
- Exp Date 05/15/2026
- 011326202030077
- 011626202030111
- Exp Date 05/20/2026
- 011926202030122
- Exp Date 05/21/2026
- 011926202030123
- 012726202030159
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Wells Pharma of Houston LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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