Injectable Phenylephrine Hydrochloride Solution Recall Due to cGMP Deviations
Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.
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: FDA classified this as a Class II recall for cGMP deviations. The source text does not report any illnesses, injuries, or adverse events; the hazard is theoretical/preventive in nature, which places this in the Moderate category per the rubric.
Plain-English summary
Wells Pharma of Houston LLC is voluntarily recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags (NDC 73702-122-03) distributed nationwide. The recall was initiated due to cGMP (current good manufacturing practice) deviations identified in the manufacturing process.
A total of 13,070 IV bags are affected by this recall. The affected product includes multiple lot numbers with expiration dates ranging from April 3, 2026 through July 10, 2026. The full list of affected lot numbers and their corresponding expiration dates has been documented by the FDA.
Consumers and healthcare facilities that have received these products should stop use and consult with Wells Pharma of Houston LLC or the FDA for instructions on the proper handling and disposition of the recalled medication. Healthcare providers are advised to review their inventories for the affected lot numbers.
The recalled product
- Product
- Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
- Manufacturer
- Wells Pharma of Houston LLC
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 13,070
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)
- 120325122032719
- Exp Date 04/03/2026
- 120425122032734 Exp Date 04/04/2026
- 120425122032735
- Exp Date 04/04/2026
- 120925122032781
- Exp Date 04/10/2026
- 010626122030010
- Exp Date
- 05/08/2026
- 010626122030009
- Exp Date 05/08/2026
- 010826122030031
- Exp Date 05/13/2026
- 010826122030032
- 011326122030072
- Exp Date 05/15/2026
- 011326122030071
- 011626122030107
- Exp Date 05/20/2026
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.
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