Clonazepam Tablets — Class III drug recall D-0135-2017
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2016-11-16, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC)
| Recall number | D-0135-2017 |
|---|---|
| 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 | 2016-09-28 |
| Classified | 2016-11-10 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2018-08-28 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 51079-0881-20, 51079-0881-56 |
Product
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
Reason for recall
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 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-0135-2017. 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.