FDA Drug recall D-0300-2025
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Nat…
- FDA Drug
- Class I
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class I recall of SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Nat… by Ascent Consumer Products, citing microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0300-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-28 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascent Consumer Products |
| Distribution | US |
Product
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
Reason
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Identifiers
| upc | 646011001034 |
|---|---|
| code_info | Lot# 024122661Al, Exp Date 12/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0300-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.