CHLORHEXIDINE GLUCO — Class II drug recall D-0975-2016
Terminated recall by Aidarex Pharmaceuticals LLC, reported 2016-06-15, distributed in CA, ND, PA, TN. Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
| Recall number | D-0975-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aidarex Pharmaceuticals LLC, Corona, CA, United States |
| Recall initiated | 2016-06-01 |
| Classified | 2016-06-08 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-10-14 |
| Distributed | CA, ND, PA, TN |
| Quantity | 292 bottles |
| Reason classes | specification failure |
| NDC | 33261-0447-01 |
| Lot numbers | 2017/01, 2017/02, 2017/03, 2017/05, 43707-1, 44359-1, 44395-1, 44693-1, 44694-1, 45335-1, 46807-1, 47697-1, 47772-1, 48271-1, 48605-1, 48659-1 |
Product
CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
Reason for recall
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
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-0975-2016. 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.