Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Chlorhexidine Gluconate Oral Rinse Recalled by Akorn Inc Due to Crystallization with subpotent out of specification assay results...
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 Akorn Inc directly.
Affected Products
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
Quantity: 541,900 unit dose cups (5,419 trays)
Why Was This Recalled?
Crystallization with subpotent out of specification assay results for chlorhexidine.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn Inc
Akorn Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report