Oxygen Nasal Wash — Class II drug recall D-1452-2016
Terminated recall by Let's Talk Health, Inc., reported 2016-08-10, distributed nationwide. Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well
| Recall number | D-1452-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Let's Talk Health, Inc., Chula Vista, CA, United States |
| Recall initiated | 2016-07-05 |
| Classified | 2016-07-29 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, LB, MY, PH |
| Quantity | 417 bottles |
| Reason classes | unapproved product |
| Lot numbers | 15522 |
Product
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
Reason for recall
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.
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-1452-2016. 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.