The Recall Desk
ModerateFDA (Drugs)·D-0216-2024·Announced 2024-01-10

OTC Nasal Decongestant Recalled Due to Manufacturing Process Deviation

Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.

What this means for you

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 a FDA Class II voluntary precautionary recall based on a manufacturing deviation with no contamination detected in finished products and no reported illnesses or injuries.

Plain-English summary

Seaway Pharma Inc. is recalling Quality Choice No Drip Extra Moisturizing Nasal Pump Mist (Oxymetazoline hydrochloride 0.05%) due to a manufacturing deviation. The firm reported possible microbial contamination in the purified water used during manufacturing. However, no contamination was found in any of the finished products.

The recall affects 7,992 bottles of Lot SE23034 with expiration date 05/31/2026, distributed in Michigan and Pennsylvania. The affected product is 1 fl oz (30 mL) bottles with NDC# 63868-676-01 and UPC 6-35515-98847-7.

Consumers who have this product should not use it and should contact their pharmacy, healthcare provider, or distributor for instructions on return or disposal.

The recalled product

Product
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE HYDROCHLORIDE)
Brand
OXYMETAZOLINE HYDROCHLORIDE
Manufacturer
Seaway Pharma Inc.
Hazard
  • microbial-contamination

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 # SE23034
  • Exp 05/31/2026

UPCs (3)

  • 0635515988439
  • 0635515988477
  • 635515988477

Distribution

Distributed in 2 states:

  • MI
  • PA

Same brand · OXYMETAZOLINE HYDROCHLORIDE