Flucanozole Tablets — Class II drug recall D-0449-2017
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2017-02-08, distributed nationwide. Failed Dissolution Specifications; 18 month stability time point
| Recall number | D-0449-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2016-12-28 |
| Classified | 2017-01-30 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-10-19 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 55111-0143, 55111-0143-01, 55111-0143-05, 55111-0143-30, 55111-0143-78, 55111-0143-79, 55111-0144, 55111-0144-01, 55111-0144-05, 55111-0144-30, 55111-0144-78, 55111-0144-79, 55111-0145, 55111-0145-12, 55111-0145-71, 55111-0146, 55111-0146-01, 55111-0146-05, 55111-0146-30, 55111-0146-78, 55111-0146-79 |
| Expiration dates | 2016-12, 2017-03 |
Product
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Reason for recall
Failed Dissolution Specifications; 18 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-0449-2017. 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.