ORIS — Class II drug recall D-0874-2016
Terminated recall by Akorn, Inc., reported 2016-06-01, distributed nationwide. Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknow
| Recall number | D-0874-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-03-23 |
| Classified | 2016-05-25 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 33,862 ml |
| Reason classes | specification failure |
| Lot numbers | 10/17, 348295, 6/16, 628146, 629690, 9/16 |
Product
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
Reason for recall
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
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-0874-2016. 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.