SinuCleanse Soft Tip NETI POT Nasal Wash System — Class I drug recall D-0301-2025
Ongoing recall by Ascent Consumer Products Inc., reported 2025-04-02, distributed nationwide. Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
| Recall number | D-0301-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascent Consumer Products Inc., Melville, NY, United States |
| Recall initiated | 2025-01-28 |
| Classified | 2025-03-25 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 00646011001027 |
| Lot numbers | 024122661AL |
| Expiration dates | 2027-12 |
Product
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
Reason for recall
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0301-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.