Ondansetron Tablet, Orally Disintegrating
FDA Recall NDC 68462-157
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ondansetron (NDC 68462-157). A significant event, classified as Class II, was initiated on Dec 30, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Dec 30, 2025
Jan 07, 2026
96,948 packs
Recall Profile & Regulatory Data
Event ID
98233
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 19251311, Exp Date April 2027
Affected Packages Involved in this Recall
68462-105-33Product
68462-105-30Product
68462-106-33Product
68462-106-30Product
68462-157-13Product
68462-158-11Product
68462-158-13Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
