SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP… recall
FDA recall D-0300-2025 · initiated Jan 28, 2025
Ascent Consumer Products Inc. recalled SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch… in Jan 2025 — an FDA Class I recall (D-0300-2025) because Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
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: unknown
Details
- 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
- Recalling company
- Ascent Consumer Products Inc.
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US.
- Initiated
- Jan 28, 2025
- FDA report date
- Apr 2, 2025
Frequently asked
- Was SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch… recalled?
- Ascent Consumer Products Inc. recalled SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch… in Jan 2025 — an FDA Class I recall (D-0300-2025) because Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch… recalled?
- Per the FDA enforcement record, the reason for recall D-0300-2025 was: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- Is a recalled SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch… 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. Most serious — a reasonable probability that use will cause serious harm or death. 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 SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch… are affected?
- Distributed: Nationwide in the US.. The recall covers these lots — Lot# 024122661Al, Exp Date 12/2027. 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-0300-2025.