Oxymetazoline Nasal Spray Recalled Due to Manufacturing Process Deviation
Seaway Pharma is recalling oxymetazoline nasal spray due to manufacturing process deviations. No contamination was found in the final products.
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 Class II manufacturing recall with no actual product contamination found and no reported illnesses or injuries. The hazard is theoretical, based on a deviation in the water purification process that did not result in contaminated products.
Plain-English summary
Seaway Pharma Inc. is recalling oxymetazoline hydrochloride nasal spray (12-hour pump mist, 1 FL oz./30 mL bottles) sold under two brands: Quality Choice and Premier Value. The recall involves Lot # SD23032 with expiration date 04/30/2026, affecting approximately 7,992 bottles distributed in Michigan and Pennsylvania.
The recall was initiated due to a manufacturing process deviation. The firm reported possible microbial contamination in the purified water used in product manufacturing. Upon investigation, no contamination was detected in any of the final products. The U.S. Food and Drug Administration classified this as a Class II recall.
Consumers who possess affected product should not use it. The product may be returned to the place of purchase. Healthcare providers and patients with questions should contact the recalling firm or the FDA.
The recalled product
- Product
- OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- OXYMETAZOLINE HYDROCHLORIDE
- Manufacturer
- Seaway Pharma Inc.
- Category
- Drug — OTC Nasal Spray
- Affected units
- 7,992
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 # SD23032
- Exp 04/30/2026
UPCs (3)
- 0635515988446
- 635515988439
- 840986035098
Distribution
Part of a larger recall action
This product is one of 4 recalled by Seaway Pharma Inc. 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 4 products in this recall →Related recalls
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