Quetiapine Fumarate Extended-Release Tablets — Class III drug recall D-0999-2020
Terminated recall by The Harvard Drug Group, reported 2020-03-18, distributed nationwide. Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fum
| Recall number | D-0999-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2020-02-27 |
| Classified | 2020-03-11 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 330 cartons |
| Reason classes | labeling |
| NDC | 00904-6801, 00904-6801-61, 00904-6802, 00904-6802-61, 00904-6803, 00904-6803-61, 00904-6804, 00904-6804-61, 00904-6805, 00904-6805-61 |
| Lot numbers | N00028, N00044 |
| Expiration dates | 2021-04, 2021-06 |
Product
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61
Reason for recall
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
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-0999-2020. 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.