FDA Drug recall D-0135-2017
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 d…
- FDA Drug
- Class III
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class III recall of 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 d… by Mylan Institutional D B A Udl Laboratories, citing failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0135-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-28 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Identifiers
| code_info | Lot#: a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17 |
|---|
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-0135-2017%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.