Class II Recall for Ondansetron Orally Disintegrating Tablets Due to Packaging Defect

The US Food and Drug Administration (FDA) has issued a Class II recall for Ondansetron Orally Disintegrating Tablets, USP, 4 mg, packaged as 30 tablets (3 blistercards of 10 tablets each). The product was manufactured in India for Glenmark Pharmaceuticals Inc., USA, and distributed under NDC 68462-157-13. The recall affects 96 948 packs from Lot #19251311, with an expiration date of April 2027. The issue was prompted by reports from Preferred Pharmaceuticals, which repackaged the product, that blister packs were not fully sealed, resulting in tablets falling out of packaging.

This voluntary recall was initiated on December 30, 2025, and officially classified as Class II by the FDA on December 31, 2025. Class II recalls involve products that may cause temporary or medically reversible adverse health effects, with a low likelihood of serious injury. Although no contamination or harm has been reported, defective blister packaging can compromise tablet integrity, reduce dose accuracy, and lead to possible product degradation. Glenmark issued notifications via letters to impacted consignees. No public press release has been issued at this time.

Ondansetron is a selective 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with chemotherapy, radiation therapy, and postoperative recovery. Pharmacists should inspect inventory for Lot #19251311, remove affected product, and coordinate with prescribers or patients for substitution or redispensing from unaffected lots. Given that this formulation is orally disintegrating, ensuring packaging integrity is essential to maintain dosing consistency and prevent unintended exposure, especially for patients requiring precise antiemetic control during treatment.

Reference
FDA. Enforcement Report. January 7, 2026. Accessed January 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm