Sunstar Paroex Oral Rinse Recall: Potential Bacterial Contamination Risk
Sunstar recalls Paroex oral rinse due to potential Burkholderia cepacia contamination from manufacturing issues. Affected lots were sold from Dec 2020 to Sep 2022. Consumers should check their product details and contact Sunstar for guidance.
Recall notice
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Contact the company
What happened, in plain English
Sunstar is recalling Paroex oral rinse products that may have bacterial contamination from manufacturing issues. This recall affects products with specific lot numbers and expiration dates, and users should stop using them if they have the affected items. Read more at govinfonow.com/recall/36562-sunstar-paroex-oral-rinse-recall-potential-bacterial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36562-sunstar-paroex-oral-rinse-recall-potential-bacterial-contamination-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0222-2021
Cite this page
“Sunstar Paroex Oral Rinse Recall: Potential Bacterial Contamination Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36562-sunstar-paroex-oral-rinse-recall-potential-bacterial-contamination-risk. Based on FDA recall #D-0222-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0222-2021%22&limit=1).
Why it’s dangerous
The FDA found potential contamination with Burkholderia cepacia complex bacteria during a manufacturing inspection. This could lead to infections, especially in people with weakened immune systems or those using the product for medical reasons. The contamination occurred due to inadequate cleaning and microbiological testing at the facility.
Who’s affected
People who have the recalled Paroex oral rinse products with specific lot numbers and expiration dates from December 2020 through September 2022 are affected. Those using the product for medical purposes are at higher risk due to potential contamination.
How to tell if you have this one
Check for the product name 'Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only' with specific lot numbers and expiration dates from December 31, 2020 through September 30, 2022.
- Brand
Sunstar- Category
Drug
What to do — step by step
Check Product Details
Look for the product name and specific lot numbers and expiration dates from December 31, 2020 through September 30, 2022.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0222-2021 (December 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0222-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.