Seaway Pharma Inc. recalls Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal
Seaway Pharma recalls Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05% for possible microbial contamination during manufacturing. No contamination found in final products.
Lower-risk recall
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Contact the company & request your remedy
What happened, in plain English
Seaway Pharma is recalling a nasal decongestant spray due to possible microbial contamination in the manufacturing process. The recall is based on a report of possible contamination in the purified water used to make the product, but no contamination was found in the final products. Read more at govinfonow.com/recall/32903-seaway-pharma-recalls-nasal-pump-mist-due-to-possible-microbial.
Source Summary by GovInfoNow · govinfonow.com/recall/32903-seaway-pharma-recalls-nasal-pump-mist-due-to-possible-microbial · Updated September 23, 2026 · FDA enforcement record: FDA #D-0216-2024
Cite this page
“Seaway Pharma recalls nasal pump mist due to possible microbial contamination in manufacturing.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32903-seaway-pharma-recalls-nasal-pump-mist-due-to-possible-microbial. Based on FDA recall #D-0216-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0216-2024%22&limit=1).
Why it’s dangerous
The recall is based on a report that the manufacturing process might have used water contaminated with microbes. However, testing found no contamination in the final product, so the risk is low.
Who’s affected
People who own or use the recalled nasal decongestant spray are affected. Those with sensitive nasal passages or allergies may be at slightly higher risk due to potential contamination concerns.
How to tell if you have this one
Check for the product name 'Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%'. The product has a 1 fl oz (30 mL) bottle, NDC# 63868-676-01, and was distributed by C.D.M.A, Inc. in Novi, MI.
- Brand
Seaway Pharma- Product
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
MI, PA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0214-2024 | Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.; Lot # SD23032, Exp 04/30/2026 | 7,992 bottles | 63868-607-01 |
| D-0215-2024 | Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.; Lot # SD23033, Exp 04/30/2025 | 4,176 bottles | — |
| D-0216-2024 | Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.; Lot # SE23034, Exp 05/31/2026 | 7,992 bottles | 63868-605-01, 63868-676-01 |
| D-0217-2024 | Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0; Lot # SE23035, Exp 05/31/2026 | 8,160 bottles | 63868-608-01 |
What to do — step by step
Check Product Details
Look for the product name, NDC# 63868-676-01, and the lot number SE23034 on the bottle.
Questions people ask
Is this product safe to use?
The recall states that no contamination was found in the final products, so the product is safe to use as long as it has not been exposed to the reported contamination during manufacturing.
Why was this product recalled?
Seaway Pharma reported possible microbial contamination in the purified water used during manufacturing, but testing found no contamination in the final product.
How can I tell if I have the recalled product?
Check for the product name 'Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%', NDC# 63868-676-01, and lot number SE23034 on the bottle.
Contact Seaway Pharma
We’ve drafted a message you can send Seaway Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0216-2024 — Seaway Pharma Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride Hello, I own a Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal that is covered by recall D-0216-2024 from Seaway Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0216-2024 (December 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0216-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.