SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant recall
FDA recall D-0569-2024 · initiated Jun 24, 2024
Neilmed Pharmaceuticals Inc recalled SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant in Jun 2024 — an FDA Class III recall (D-0569-2024) because Sub-potent Drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Sub-potent Drug
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 20,370 bottles
Details
- Product
- 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.
- Recalling company
- Neilmed Pharmaceuticals Inc
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Jun 24, 2024
- FDA report date
- Jul 3, 2024
Frequently asked
- Was SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant recalled?
- Neilmed Pharmaceuticals Inc recalled SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant in Jun 2024 — an FDA Class III recall (D-0569-2024) because Sub-potent Drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant recalled?
- Per the FDA enforcement record, the reason for recall D-0569-2024 was: Sub-potent Drug
- Is a recalled SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot: SD134; Exp: 10/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0569-2024.