Table of contents
- Latest Paroex Oral Rinse Recall Updates
- December 28, 2020: Sunstar Expands the Paroex Recall
- October 27, 2020: Sunstar Recalls Paroex Oral Rinse
- Which Paroex Oral Rinse Are Affected?
- Why Was Paroex Oral Rinse Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Frequently Asked Questions
- What Is Paroex Oral Rinse Used For?
- Did the FDA Issue the Paroex Recall?
- What Are the Symptoms of Infection from Paroex?
- Is GUM Paroex Part of the Recall?
Sunstar Americas recalled Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%. The prescription rinse has possible contamination with Burkholderia lata bacteria. The voluntary recall to the consumer level began on October 27, 2020.
Sunstar expanded the recall in December 2020. It now covers all lots expiring from December 31, 2020 through September 30, 2022. The FDA posted both notices. Sunstar reported 29 adverse events by the expansion.
Patients, pharmacies and healthcare facilities should stop using and dispensing the rinse right away. As of October 2026, no lawsuit, class action or MDL names Paroex Oral Rinse.
Latest Paroex Oral Rinse Recall Updates
December 28, 2020: Sunstar Expands the Paroex Recall
Sunstar announced on December 28, 2020 that it was expanding the recall. The FDA posted the expansion notice the same day [1].
The expansion adds Paroex lots with later expiration dates, running through September 30, 2022. That widened the first recall to cover all lots in that range.
October 27, 2020: Sunstar Recalls Paroex Oral Rinse
Sunstar announced a voluntary nationwide recall on October 27, 2020. It covered Paroex lots expiring from 6/30/22 through 9/30/22 and reached the consumer level.
The FDA posted the announcement on October 28, 2020 [2]. It was notifying distributors and customers by USPS Priority mail. The notice listed the lots by number and expiration date.
Which Paroex Oral Rinse Are Affected?
The recall covers the 0.12% chlorhexidine rinse in two bottle sizes:
- 16 fl oz amber bottles, packed in cases of 6: NDC 052376-021-02, code 1789P.
- The smaller 4 fl oz size has NDC 052376-021-04 and code 1788P, packed in cases of 24.
Examples from the first notice are C170FY and C240GM for the 16 fl oz bottle, and C191KR for the 4 fl oz bottle. Lot numbers and expiration dates appear in the notice tables.
Sunstar distributed the rinse nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies. Sunstar has not published a sale period or a price.
Why Was Paroex Oral Rinse Recalled?
Paroex Oral Rinse was recalled because it may be contaminated with the bacteria Burkholderia lata. This is Sunstar’s statement, as posted by the FDA. It is not an FDA finding.
Sunstar says use of the product in an immunocompetent host may lead to oral infections. It says systemic infections are also possible. It says these infections need antibacterial therapy.
Reported Incidents, Injuries, or Illnesses
Sunstar reported 29 adverse events as of the December 28, 2020 notice. None had been reported at the October 27, 2020 notice. The reports went to the company, and Sunstar has not published a cutoff date or location.
Sunstar says the product may cause life-threatening infections in the most at-risk groups. It says affected patients tested positive for Burkholderia lata. The germ was typically found in sputum cultures. These patients were under treatment for other serious conditions.
Sunstar also says the rinse is particularly unsafe for patients with lung conditions. That includes patients infected with Covid-19. These are company statements. The reports do not prove the rinse caused every event.
What Should Consumers Do?
The FDA notice and Sunstar give patients, pharmacies and dental offices these steps:
- Stop using and dispensing any recalled Paroex right away.
- Look for Sunstar to arrange the return of all recalled products.
- Contact Sunstar at 1-800-528-8537 or us.pcr@us.sunstar.com. Hours are Monday through Friday, 8am to 5pm CST.
- See a doctor or other healthcare provider if you had problems that may relate to using the rinse. The notice describes oral and systemic infections.
- Report side effects to the FDA through its MedWatch program.
- Dental offices that prescribed the rinse should notify patients of the recall, says the California Dental Association [3].
Frequently Asked Questions
What Is Paroex Oral Rinse Used For?
Paroex Oral Rinse, sold in the US by Sunstar Americas as GUM Paroex, is used as part of a professional program for treating gingivitis. It is a prescription rinse that Sunstar makes with chlorhexidine gluconate. It is available through healthcare professionals only.
Did the FDA Issue the Paroex Recall?
The FDA did not issue the Paroex recall. Sunstar announced it voluntarily, and the FDA posted the company announcements as a public service. The FDA states that it does not endorse either the product or the company.
What Are the Symptoms of Infection from Paroex?
Infection from Paroex may start in the mouth and, potentially, spread through the body. Sunstar says the most at-risk patients may develop life-threatening infections such as pneumonia and bacteremia. Contact a healthcare provider about any problem that may relate to the rinse.
Is GUM Paroex Part of the Recall?
GUM Paroex is part of the recall because it is the same rinse as Paroex Oral Rinse, made by Sunstar Americas. Check the bottle size, product code 1789P or 1788P, and the expiration date against the notice.