Halyard Oral Rinse Recall: Crystallization Risk
Akorn recalls Halyard 24-Hour Oral Care Kits due to chlorhexidine crystallization and subpotent results. Check lot numbers and expiration dates.
Use caution until it’s fixed
Crystallization with subpotent out of specification assay results for chlorhexidine.
Contact the company
What happened, in plain English
Akorn Inc is recalling Halyard 24-Hour Oral Care Kit q2 products because the oral rinse may contain crystals and have lower-than-specified levels of chlorhexidine. This issue affects specific lots distributed nationwide with expiration dates in June and July 2018. The record does not specify a remedy or return process for consumers. Read more at govinfonow.com/recall/41505-halyard-oral-rinse-recall-crystallization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41505-halyard-oral-rinse-recall-crystallization-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-1089-2017
Cite this page
“Halyard Oral Rinse Recall: Crystallization Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41505-halyard-oral-rinse-recall-crystallization-risk. Based on FDA recall #D-1089-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1089-2017%22&limit=1).
Why it’s dangerous
The product contains crystallization and has subpotent assay results for chlorhexidine, meaning the active ingredient may be less effective than labeled. This could result in inadequate oral care or infection prevention if the rinse does not perform as intended.
Who’s affected
Consumers who purchased the Halyard 24-Hour Oral Care Kit q2 containing 2x15 mL unit dose cups of 0.12% Chlorhexidine Gluconate Oral Rinse. Individuals using these specific lots before their expiration dates are potentially affected.
How to tell if you have this one
Look for the Halyard 24-Hour Oral Care Kit q2 containing 2x15 mL unit dose cups of 0.12% Chlorhexidine Gluconate Oral Rinse. Check the REF number 97012 and verify if your lot numbers match: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209 (EXP 06-2018) or 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434 (EXP 07-2018).
- Brand
Halyard- 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-1088-2017 | 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.; Lot: 353394, Exp 10-2018 | 541,900 unit dose cups (5,419 trays) |
| D-1089-2017 | Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012; Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018. | 40,978 unit dose cups |
| D-1090-2017 | Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014; Lots: 0202635072, 0202635073, EXP 06-2018; 0202630205, 0202630206, EXP 07-2018; 0202630203, 0202630204, 0202642217, 0202642218, 0202642219, 0202647410, 0202647411, EXP 08-2018; 0202647409, 0202647412, 0202653431, 0202653432, EXP 09-2018. | 101,952 15 mL unit dose cups |
What to do — step by step
Check Your Lot Numbers
Compare the lot numbers on your Halyard Oral Care Kit against the recalled lots listed in the record to see if your product is included.
Verify Expiration Date
Ensure your kit has an expiration date of 06-2018 or 07-2018, as these are the dates associated with the affected lots.
Contact Manufacturer for Guidance
Since the remedy is not stated in the record, contact Halyard Health Inc. or Akorn Inc. directly for instructions on what to do with the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1089-2017 (July 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1089-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.