Ondansetron Orally Disintegrating Tablets recall
FDA recall D-0246-2026 · initiated Dec 30, 2025
Glenmark Pharmaceuticals Inc., USA recalled Ondansetron Orally Disintegrating Tablets in Dec 2025 — an FDA Class II recall (D-0246-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 96,948 packs
Details
- 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
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Dec 30, 2025
- FDA report date
- Jan 7, 2026
Frequently asked
- Was Ondansetron Orally Disintegrating Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Ondansetron Orally Disintegrating Tablets in Dec 2025 — an FDA Class II recall (D-0246-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ondansetron Orally Disintegrating Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0246-2026 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.
- Is a recalled Ondansetron Orally Disintegrating Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ondansetron Orally Disintegrating Tablets are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 19251311, Exp Date April 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0246-2026.