Deferasirox Tablets for Oral Suspension — Class II drug recall D-0095-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2023-11-15, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0095-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2023-10-20 |
| Classified | 2023-11-08 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 5,856 bottles |
| Reason classes | specification failure |
| NDC | 68462-0494, 68462-0494-30, 68462-0494-90, 68462-0495, 68462-0495-30, 68462-0495-90, 68462-0496, 68462-0496-30, 68462-0496-90 |
| Lot numbers | 17220063, 17220396, 17220397, 17220965, 17221187, 17221523, 17221793, 17221794, 17221801 |
| Expiration dates | 2023-12, 2024-01, 2024-04, 2024-07, 2024-08 |
Product
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
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-0095-2024. 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.