Paliperidone Extended-release Tablets — Class II drug recall D-0840-2016
Terminated recall by Mylan Pharmaceuticals Inc., reported 2016-05-18, distributed nationwide. Failed Dissolution Specifications; three month stability time point.
| Recall number | D-0840-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2016-02-12 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2016-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 2,928 bottles |
| Reason classes | specification failure |
| NDC | 00378-3978-93 |
| Lot numbers | 0378-3978-93, 2005441 |
Product
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Reason for recall
Failed Dissolution Specifications; three month stability time point.
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-0840-2016. 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.