CLASS III ONGOING Drug recall · Reported 3 Jul 2024 · FDA Enforcement Report
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution recalled
Neilmed Pharmaceuticals is recalling SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant, distributed nationwide in the US. The recall was initiated on 24 Jun 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0569-2024
- FDA event ID
- 94853
- Recalling firm
- Neilmed Pharmaceuticals, Santa Rosa, CA
- Manufacturer
- Neilmed pharmaceuticals Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 24 Jun 2024
- FDA classified
- 28 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Nasal Sprays
Timeline
| 24 Jun 2024 | Recall initiated by company | |
| 28 Jun 2024 | Classified by FDA | +4 days |
| 3 Jul 2024 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potent Drug
Product as listed by the FDA
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Sub-potent Drug
Which lots are affected?
Lot: SD134; Exp: 10/31/2026
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Neilmed Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NeiMed NasoGel for DRY Noses recalled by Neilmed Pharmaceuticals | Neilmed Pharmaceuticals | Potency & Assay | Nationwide |