Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Paroex (chlorhexidine gluconate) Oral Rinse Recalled by Sunstar Americas, Inc. Due to Microbial Contamination of Non-sterile Products: contamination with Burkholderia...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sunstar Americas, Inc. directly.
Affected Products
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
Quantity: a) 116,662 bottles; b) 13,296 bottles
Why Was This Recalled?
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sunstar Americas, Inc.
Sunstar Americas, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report