Loxapine Capsules — Class II drug recall D-0824-2018
Terminated recall by Mylan Pharmaceuticals Inc., reported 2018-05-30, distributed nationwide. CGMP Deviations
| Recall number | D-0824-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2018-04-24 |
| Classified | 2018-05-22 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2019-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 8,679 bottles |
| Reason classes | cgmp |
| NDC | 00378-7025-01 |
| Lot numbers | 3083756, 3083757, 3083758, 3083759, 3083760, 3083761 |
| Expiration dates | 2019-03-31 |
Product
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Reason for recall
CGMP Deviations
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-0824-2018. 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.