CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report
NeiMed NasoGel for DRY Noses recalled by Neilmed Pharmaceuticals
Neilmed Pharmaceuticals is recalling NeiMed NasoGel for DRY Noses, distributed nationwide in the US. The recall was initiated on 28 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1105-2025
- FDA event ID
- 96076
- Recalling firm
- Neilmed Pharmaceuticals, Santa Rosa, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Dec 2024
- FDA classified
- 5 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 28 Dec 2024 | Recall initiated by company | |
| 5 Feb 2025 | Classified by FDA | +39 days |
| 12 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to nasal spray stability failure for bioburden.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.
Where it was distributed
Worldwide - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, VA, VT, WA, and WI. The countries of Bahrain, Ireland, Malaysia, Mexico, and United Kingdom.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisIndianaKentuckyMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew MexicoNew York
Questions about this recall
Why was it recalled?
Due to nasal spray stability failure for bioburden.
Which lots are affected?
NasoGel Spray UDI-DI/UPC code: 00705928045309 SKU / Lot Numbers: GSP30-2R-48-ENU-USL / NGS751 GSP30-0R-96-ENU-USL / NGS757 and NGS762 GSP30-ARA-INTL / NGS762 GSP30-SWE-INTL / NGS754 GSP30-ENG-INT / NGS755 GSP30-MAL-INTL / NGS756 GSP30-SPA-INT / NGS760 and NGS761
Where was it sold?
Worldwide - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, VA, VT, WA, and WI. The countries of Bahrain, Ireland, Malaysia, Mexico, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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