FDA Drug recall D-0095-2024
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ…
- FDA Drug
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ… by Glenmark Pharmaceuticals Usa, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0095-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-20 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 68462-494-30 |
|---|---|
| ndc | 68462-494-90 |
| ndc | 68462-495-30 |
| ndc | 68462-495-90 |
| ndc | 68462-496-30 |
| ndc | 68462-496-90 |
| code_info | Lot #: 17220063, Exp 12/2023; 17220396, 17220397, Exp 01/2024; 17220965, Exp 04/2024; 17221187, 17221523, Exp 07/2024; 17221793, 17221794, 17221801, Exp 08/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0095-2024%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.