Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Paroex (Chlorhexidine Gluconate) Oral Rinse Recalled by Sunstar Americas, Inc. Due to cGMP Deviations; FDA inspection of manufacturing facility observed...
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 (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
Quantity: a) 1,021,914 bottles; b) 255,552 bottles
Why Was This Recalled?
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
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