Imatinib Mesylate Tablets 100mg — Class II drug recall D-0287-2021
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-03-03, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0287-2021 |
|---|---|
| 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 | 2021-02-17 |
| Classified | 2021-02-24 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2022-12-21 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 43598-0344, 43598-0344-10, 43598-0344-30, 43598-0344-31, 43598-0344-90, 43598-0345, 43598-0345-05, 43598-0345-30, 43598-0345-31, 43598-0345-90 |
Product
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India.
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-0287-2021. 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.