Halyard 24-Hour Oral Care Kit q2 — Class III drug recall D-1089-2017
Terminated recall by Akorn Inc, reported 2017-08-23, distributed nationwide. Crystallization with subpotent out of specification assay results for chlorhexidine.
| Recall number | D-1089-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2017-07-12 |
| Classified | 2017-08-14 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2018-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 40,978 units |
| Reason classes | potency, specification failure |
| Lot numbers | 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434 |
| Model numbers | 97012 |
| Expiration dates | 2018-06, 2018-07 |
Product
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
Reason for recall
Crystallization with subpotent out of specification assay results for chlorhexidine.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1089-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.