Ondansetron Tablets Recalled Due to Unsealed Blister Packs
Glenmark Pharmaceuticals is recalling Ondansetron 4mg tablets because blister packs are not fully sealed, allowing tablets to fall out. The recall affects 96,948 packs distributed nationwide, lot number 19251311.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with no reported illnesses or injuries. The defect is a manufacturing issue affecting product integrity; this qualifies as a risk-of-harm product without yet-reported injury, meeting High (3) severity criteria.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Ondansetron Orally Disintegrating Tablets, USP, 4mg. The affected product consists of approximately 96,948 packs distributed nationwide, identified by lot number 19251311 with an expiration date of April 2027. Each package contains 30 tablets in 3 blister cards of 10 tablets each.
The tablets are being recalled due to a defect in which the blister packs are not fully sealed. Tablets are falling out of the packages, which compromises product integrity and protection.
The recalled product
- Product
- ONDANSETRON (ONDANSETRON)
- Brand
- ONDANSETRON
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- defective-seal
- tablet-loss
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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