FDA Recall D-0299-2025

Ascent Consumer Products Inc. · Melville, NY

Class I — life-threatening Ongoing 471 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1

Lot / code: Lot# 024122661Al, Exp Date 12/2027

Quantity: 4,176 cartons

Reason for recall

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Recall record

Recall number: D-0299-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the US.
Recall initiated: 2025-01-28
Classified by FDA Center: 2025-03-25
FDA published: 2025-04-02
Recalling firm: Ascent Consumer Products Inc.
Firm location: Melville, NY

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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