FDA Drug recall D-0246-2026
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Gle…
- FDA Drug
- Class II
- ongoing
- Published 2026-01-07
On 2026-01-07 the FDA classified a Class II recall of Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Gle… by Glenmark Pharmaceuticals Usa, citing defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pha….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0246-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-30 |
| Published | 2026-01-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Reason
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Identifiers
| ndc | 68462-105-33 |
|---|---|
| ndc | 68462-105-30 |
| ndc | 68462-106-33 |
| ndc | 68462-106-30 |
| ndc | 68462-157-13 |
| ndc | 68462-158-11 |
| ndc | 68462-158-13 |
| code_info | Lot #: 19251311, Exp Date April 2027 |
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-0246-2026%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.