Rexall Sinus Nasal Pump Mist Recalled for Quality Control Issues
Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump Mist due to manufacturing deviations that could impact product quality.
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: The recall is classified as FDA Class II due to CGMP deviations that could impact quality, but no specific illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump Mist, containing Oxymetazoline Hydrochloride 0.05%, in 1 FL OZ (30mL) bottles. The recall is being conducted because the products were manufactured under conditions that could impact product quality, specifically involving Current Good Manufacturing Practice (CGMP) deviations.
The affected product is identified by SKU 00744201. The recall covers all lots remaining within their expiration dates. The product was distributed nationwide in the USA.
Consumers who have this product should stop using it and contact the manufacturer or their point of purchase for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Hazard
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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Product Quest Manufacturing 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.
See all 54 products in this recall →Related recalls
Same manufacturer · Product Quest Manufacturing LLC
See all →- ModeratePremier Value Sterile Saline Nasal Mist Recalled for Quality Concerns
FDA (Drugs) · 2018-10-24
- ModerateRhinall Nasal Decongestant Spray Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2018-10-24
- ModerateRhinall Nasal Decongestant Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2018-10-24
- ModerateCVS Health Saline Nasal Spray Recalled for Manufacturing Deviations
FDA (Drugs) · 2018-10-24
- ModerateRite Aid Nasal Spray Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2018-10-24
Same hazard · quality control
See all →- HighBaxter Recalls CARDENE IV Nicardipine Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls MYXREDLIN Insulin Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateNasal Decongestant Recalled for Possible Manufacturing Water Contamination
FDA (Drugs) · 2024-01-10
- ModerateOTC Nasal Decongestant Recalled Due to Manufacturing Process Deviation
FDA (Drugs) · 2024-01-10
- ModerateNasal Mist Oxymetazoline HCl Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateOxymetazoline Nasal Spray Recalled Due to Manufacturing Process Deviation
FDA (Drugs) · 2024-01-10
- ModeratePerrigo Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateNasal Spray Oxymetazoline HCl Recalled Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02