FDA Drug recall D-0287-2021
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90)
- FDA Drug
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90) by Dr Reddy S Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0287-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-17 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 43598-344-30 |
|---|---|
| ndc | 43598-344-90 |
| ndc | 43598-344-10 |
| ndc | 43598-344-31 |
| ndc | 43598-345-30 |
| ndc | 43598-345-90 |
| ndc | 43598-345-05 |
| ndc | 43598-345-31 |
| code_info | Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0287-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.