Fentanyl Citrate Injectable Solution Recall Due to cGMP Deviations
Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes 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 for cGMP deviations affecting a sterile injectable drug. The source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, Class II recalls without reported adverse health consequences are typically Moderate (score 2).
Plain-English summary
Wells Pharma of Houston LLC is recalling fentanyl citrate injectable solution in 0.9% sodium chloride, 1000 mcg/50 mL (20 mcg per mL), NDC 73702-203-65, due to current good manufacturing practice (cGMP) deviations. The recall involves 150 syringes with lot number 022326203650432 and an expiration date of 06/25/2026.
The affected product was distributed nationwide throughout the United States. This is a voluntary recall initiated by the firm on April 1, 2026, and classified by the FDA as a Class II recall.
Patients and healthcare providers who have this product should stop use and consult with their healthcare provider regarding appropriate alternatives. Healthcare facilities should check their inventory for the affected lot and remove it from distribution.
The recalled product
- Product
- fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
- Manufacturer
- Wells Pharma of Houston LLC
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 150
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 022326203650432
- Exp Date 06/25/2026
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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