Chlorhexidine Gluconate Oral Rinse — Class III drug recall D-1088-2017
Terminated recall by Akorn Inc, reported 2017-08-23, distributed nationwide. Crystallization with subpotent out of specification assay results for chlorhexidine.
| Recall number | D-1088-2017 |
|---|---|
| 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) |
| Reason classes | potency, specification failure |
| NDC | 50383-0720-15, 50383-0720-19 |
| Lot numbers | 353394 |
| Expiration dates | 2018-10 |
Product
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.
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-1088-2017. 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.