FDA Drug recall D-0650-2016
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-88…
- FDA Drug
- Class III
- terminated
- Published 2016-02-10
On 2016-02-10 the FDA classified a Class III recall of Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-88… by Mylan Institutional D B A Udl Laboratories, citing failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0650-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-01-28 |
| Published | 2016-02-10 |
| 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, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Reason
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Identifiers
| code_info | Lot # 3063759, Exp.07/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Mylan Institutional D B A Udl Laboratories
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FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories - Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carto…
FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories - Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 5…
FDA Drug · Class II · 2019-03-27 · Mylan Institutional D B A Udl Laboratories - Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by:…
FDA Drug · Class III · 2018-08-29 · Mylan Institutional D B A Udl Laboratories - Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2018-05-30 · Mylan Institutional D B A Udl Laboratories
All Mylan Institutional D B A Udl Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0650-2016%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.