Mirtazapine Tablets — Class II drug recall D-0492-2017
Terminated recall by Mylan Pharmaceuticals Inc., reported 2017-03-15, distributed nationwide. Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
| Recall number | D-0492-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2017-01-19 |
| Classified | 2017-03-08 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2017-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 37,445 bottles |
| NDC | 00378-3515, 00378-3515-01, 00378-3515-10, 00378-3515-70, 00378-3515-93, 00378-3530, 00378-3530-01, 00378-3530-05, 00378-3530-70, 00378-3530-93, 00378-3545, 00378-3545-01, 00378-3545-05, 00378-3545-70, 00378-3545-93 |
| Expiration dates | 2019-08-20 |
Product
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Reason for recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
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-0492-2017. 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.