Ondansetron tablets recalled because blister packs are not fully sealed
Glenmark Pharmaceuticals is recalling 96,948 packs of Ondansetron Orally Disintegrating Tablets, 4mg, because the blister packs are not fully sealed and tablets are falling out.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an unsealed blister pack with no stated clinical consequence or reported harm.
Plain-English summary
Ondansetron Orally Disintegrating Tablets, USP, 4mg, sold as 30 tablets in 3 blister cards of 10, manufactured for Glenmark Pharmaceuticals Inc., USA of Mahwah, New Jersey, a product of India, under NDC 68462-157-13, is being recalled.
The reason given in the enforcement record is a defective container. The record states that Preferred Pharmaceuticals received a letter from the manufacturer, Glenmark, that the blister packs are not fully sealed and tablets are falling out, and that Preferred Pharmaceuticals purchased the finished product and repackaged it for sale.
The recall covers 96,948 packs from lot 19251311, expiry April 2027. Distribution was nationwide within the United States. The FDA has classified the action as Class II.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific pack is affected and arrange a replacement.
The recalled product
- Product
- ONDANSETRON (ONDANSETRON)
- Brand
- ONDANSETRON
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Antiemetic
- Affected units
- 96,948
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 19251311
- Exp Date April 2027
UPCs (4)
- 0368462157138
- 0368462106303
- 0368462105306
- 0368462158111
Distribution
Distributed nationwide across the United States.
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