FDA Drug recall D-0874-2016
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professio…
- FDA Drug
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professio… by Akorn, citing failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0874-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-23 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
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
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Identifiers
| code_info | Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0874-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.