Let's Talk Health Recalls Oxygen Nasal Wash Over Drug Claims
Let's Talk Health recalls 417 bottles of Oxygen Nasal Wash due to unapproved drug claims. Check your lot #15522 for details.
Recall notice
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Contact the company
What happened, in plain English
Let's Talk Health, Inc. is recalling its Oxygen Nasal Wash solution because it is marketed as an unapproved new drug. The product makes nasal decongestant claims that do not comply with the FDA's final monograph for over-the-counter nasal decongestants. This recall affects 417 bottles distributed nationwide and internationally. Read more at govinfonow.com/recall/42559-let-s-talk-health-recalls-oxygen-nasal-wash-over-drug.
Source Summary by GovInfoNow · govinfonow.com/recall/42559-let-s-talk-health-recalls-oxygen-nasal-wash-over-drug · Updated October 9, 2026 · FDA enforcement record: FDA #D-1452-2016
Cite this page
“Let's Talk Health Recalls Oxygen Nasal Wash Over Drug Claims.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42559-let-s-talk-health-recalls-oxygen-nasal-wash-over-drug. Based on FDA recall #D-1452-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1452-2016%22&limit=1).
Why it’s dangerous
The product is considered a hazard because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). It makes nasal decongestant claims that violate the regulatory requirements for such products, meaning its safety and efficacy have not been established through the standard approval process.
Who’s affected
Consumers who purchased the .75 oz (22mL) bottle of Oxygen Nasal Wash solution between unspecified dates. The record does not specify which health conditions or user groups are most at risk.
How to tell if you have this one
Look for a .75 oz (22mL) bottle of Oxygen Nasal Wash solution containing purified water, xylitol, stabilized oxygen, and sodium chloride. The specific recalled lot number is #15522. The product was distributed by Let's Talk Health in Chula Vista, CA.
- Brand
Let's Talk Health- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle matches the description and has lot number #15522.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
It was distributed nationwide in the U.S. as well as in Australia, Austria, Canada, Lebanon, Malaysia, and the Philippines.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1452-2016 (July 5, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1452-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.