Akorn, Inc. recalls 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine
Akorn recalls 24-Hour Oral Care q2 Kit with Ballard Technology containing chlorhexidine that may have low drug potency due to crystallization. This could affect treatment effectiveness. Consumers should contact Akorn for details.
Lower-risk recall
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling a 24-hour oral care kit that contains chlorhexidine rinse. The product may have crystallized, leading to lower drug potency and potentially reducing treatment effectiveness. This recall affects people using the kit for medical purposes. Read more at govinfonow.com/recall/40709-akorn-24-hour-oral-care-kit-recall-subpotent-chlorhexidine-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40709-akorn-24-hour-oral-care-kit-recall-subpotent-chlorhexidine-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0612-2018
Cite this page
“Akorn 24-Hour Oral Care Kit Recall: Subpotent Chlorhexidine Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40709-akorn-24-hour-oral-care-kit-recall-subpotent-chlorhexidine-risk. Based on FDA recall #D-0612-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0612-2018%22&limit=1).
Why it’s dangerous
The chlorhexidine in the rinse may crystallize, causing the product to have lower-than-stated drug potency. This could reduce the effectiveness of the treatment for medical use, but it does not pose a direct health risk like injury or death.
Who’s affected
People using this oral care kit for medical purposes, particularly those with specific conditions requiring chlorhexidine. Those with compromised immune systems or chronic conditions may be at higher risk.
How to tell if you have this one
Check for the 24-Hour Oral Care q2 Kit with Ballard Technology containing 2 toothbrush packs and chlorhexidine rinse. The kit has specific lot numbers and expiration dates listed in the recall notice.
- Brand
Akorn- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0611-2018 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.; Lot #: 350836, Exp 05/18 | 56,1800 unit dose cups |
| D-0612-2018 | 24-HOUR Oral Care q2 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 97012.; Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202511399, 0202511400, 0202543553, Exp 03/18; 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225, Exp 04/18 | 48,176 unit dose cups |
| D-0613-2018 | 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.; Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/18; 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, Exp 04/18 | 20,587 unit dose cups |
What to do — step by step
Contact Akorn
Reach out to Akorn directly for specific instructions on how to handle the recalled product.
Questions people ask
Is this product safe to use?
The product may have lower drug potency due to crystallization, which could affect treatment effectiveness. It is not recommended for use as intended.
What should I do if I have this product?
Contact Akorn directly for specific instructions on how to handle the recalled product.
How can I tell if I have the recalled product?
Check for the 24-Hour Oral Care q2 Kit with Ballard Technology containing 2 toothbrush packs and chlorhexidine rinse. The kit has specific lot numbers and expiration dates listed in the recall notice.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0612-2018 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0612-2018 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0612-2018 (March 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0612-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.