Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
24-HOUR Oral Care q4 Kit with Ballard* Technology Recalled by Akorn, Inc. Due to Subpotent Drug: Product crystallization with accompanying low out...
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
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.
Quantity: 20,587 unit dose cups
Why Was This Recalled?
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn, Inc.
Akorn, Inc. has 176 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report