Clonazepam Tablets — Class III drug recall D-0650-2016
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2016-02-10, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepo
| Recall number | D-0650-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2016-01-28 |
| Classified | 2016-02-02 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-12-21 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 51079-0881-21 |
| Lot numbers | 07/16, 3063759 |
Product
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Reason for recall
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
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-0650-2016. 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.