Nasal Decongestant Recalled for Possible Manufacturing Water Contamination
Quality Choice No Drip Nasal Decongestant is being recalled because purified water used in manufacturing may have contained microbial contamination. No contamination was detected 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: This is an FDA Class II recall with no reported contamination in the final product and no reported illnesses or injuries. The hazard is theoretical, based on a manufacturing deviation. Per the rubric, precautionary recalls with no contamination detected in the finished product fall under the Moderate category.
Plain-English summary
Quality Choice No Drip Severe Congestion Nasal Pump Mist is an over-the-counter nasal decongestant containing 0.05% oxymetazoline hydrochloride. Seaway Pharma Inc. is recalling this product due to a manufacturing process deviation.
The manufacturer reported that purified water used in the manufacturing process may have been contaminated with microbes. As a precautionary measure, the company initiated a recall. No contamination was detected in the final products.
The recall affects 8,160 bottles distributed in Michigan and Pennsylvania. The affected lot is Lot #SE23035 with an expiration date of May 31, 2026 (NDC 63868-608-01, UPC 6-35515-98846-0).
The recalled product
- Product
- OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- OXYMETAZOLINE HYDROCHLORIDE
- Manufacturer
- Seaway Pharma Inc.
- Category
- Drug — Nasal Decongestant
- Hazard
- Affected units
- 8,160
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 # SE23035
- Exp 05/31/2026
UPCs (1)
- 635515988460
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
Same brand · OXYMETAZOLINE HYDROCHLORIDE
- ModerateOxymetazoline Nasal Spray Recalled Due to Manufacturing Process Deviation
FDA (Drugs) · 2024-01-10
- ModerateOTC Nasal Decongestant Recalled Due to Manufacturing Process Deviation
FDA (Drugs) · 2024-01-10
Same manufacturer · Seaway Pharma Inc.
See all →- ModerateOTC Cough Medicine Recalled for Potential Water Contamination Risk
FDA (Drugs) · 2024-01-10
Same hazard · microbial contamination
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