SinuFrin Nasal Decongestant Recalled for Sub-Potency Nationwide
NeilMed Pharmaceuticals is recalling 20,370 bottles of SinuFrin Quick Relief Decongestant (Lot SD134) nationwide due to sub-potency. No illnesses have been reported.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This FDA Class III voluntary recall involves a sub-potency issue with no reported illnesses or injuries. The hazard is reduced efficacy rather than a direct safety concern. Per the rubric, Class III recalls are typically assigned scores of 1 or 2; with no adverse health outcomes reported, this is classified as Low.
Plain-English summary
SinuFrin Quick Relief Decongestant (oxymetazoline HCl) 0.5 fl oz nasal solution bottles manufactured by NeilMed Pharmaceuticals Inc are being recalled nationwide. The recalled product is Lot SD134 with expiration date 10/31/2026. Approximately 20,370 bottles were distributed across the United States.
The reason for the recall is that the product has been determined to be sub-potent, meaning it contains less of the active ingredient than specified. This makes the decongestant less effective than intended, though the product does not pose a direct safety hazard.
The recall was initiated voluntarily by the manufacturer on June 24, 2024, and was classified as FDA Class III on June 28, 2024. No illnesses or injuries have been reported in connection with this product.
Consumers who have purchased this product should stop using it. For information regarding product return or replacement, contact NeilMed Pharmaceuticals Inc at 877-477-8633.
The recalled product
- Product
- SINUFRIN QUICK RELIEF DECONGESTANT (SINUFRIN)
- Brand
- SINUFRIN QUICK RELIEF DECONGESTANT
- Manufacturer
- Neilmed Pharmaceuticals Inc
- Category
- Drug — Nasal Decongestant
- Hazard
- sub-potency
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: SD134
- Exp: 10/31/2026
UPCs (1)
- 705928090019
Distribution
Distributed nationwide across the United States.
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