Fluconazole Tablets — Class II drug recall D-0689-2017
Terminated recall by The Harvard Drug Group, reported 2017-05-10, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0689-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2017-01-05 |
| Classified | 2017-04-28 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2017-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 914 cartons |
| Reason classes | specification failure |
| NDC | 00904-6500, 00904-6500-06, 00904-6500-61, 00904-6501, 00904-6501-06, 00904-6501-61 |
| Lot numbers | 01-17, T-00519 |
Product
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
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-0689-2017. 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.