Chlorhexidine Gluconate Oral Rinse — Class III drug recall D-0611-2018
Terminated recall by Akorn, Inc., reported 2018-04-04, distributed nationwide. Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine a
| Recall number | D-0611-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2018-03-29 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 56,180 |
| Reason classes | potency, specification failure |
| NDC | 50383-0720-15, 50383-0720-18, 50383-0720-19 |
| Lot numbers | 05/18, 350836 |
Product
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.
Reason for recall
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
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-0611-2018. 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.