PALIPERIDONE EXTENDED-RELEASE TABLETS — Class II drug recall D-0649-2022
Terminated recall by The Harvard Drug Group, reported 2022-03-16, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0649-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2022-02-28 |
| Classified | 2022-03-09 |
| Reported by FDA | 2022-03-16 |
| Terminated | 2023-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 174 cartons |
| Reason classes | specification failure |
| NDC | 00904-6935, 00904-6935-61, 00904-6936, 00904-6936-61, 00904-6937, 00904-6937-61 |
| Lot numbers | N00522, N00618 |
| Expiration dates | 2022-09, 2022-11 |
Product
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
Reason for recall
Failed Dissolution Specifications
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-0649-2022. 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.