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# Sunstar Americas Expands Paroex Recall
- URL: https://www.fdaweb.com/sunstar-americas-expands-paroex-recall/
- Published: 2021-01-04T12:00:00.000Z
- Updated: 2026-09-14T16:41:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148354

FDA says Sunstar Americas has expanded its nationwide recall of Paroex chlorhexidine gluconate oral rinse 0.12% due to microbial contamination. The expanded recall covers products bearing an expiration date from 12/31/20 to 9/30/22, according to an agency [notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-expands-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse?ref=fdaweb.com). The notice says the product may be contaminated with the bacteria *Burkholderia lata*.

To date, 29 adverse events have been reported to the company related to the recall, the agency says. “Affected patients tested positive for *Burkholderia lata* infections, typically found in sputum cultures while under treatment for other serious medical conditions,” the notice says. “Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.”

The company says Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.