Ondansetron Orally Disintegrating Tablets, USP, 4mg
Recalled by Glenmark Pharmaceuticals Inc., USA
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Glenmark Pharmaceuticals Inc., USA has recalled Ondansetron Orally Disintegrating Tablets, USP, 4mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on January 7, 2026 and was initiated on December 30, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Ondansetron Orally Disintegrating Tablets, USP, 4mg, with approximately 96,948 packs affected. The company behind the recall is Glenmark Pharmaceuticals Inc., USA, based in Elmwood Park, NJ. The FDA describes the product as: “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”
Why was Ondansetron Orally Disintegrating Tablets, USP, 4mg recalled?
According to the FDA, the stated reason for the recall is: “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.”
What should you do?
If you think you may have bought Ondansetron Orally Disintegrating Tablets, USP, 4mg, compare it against the product description and identifying codes (Lot #: 19251311, Exp Date April 2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Glenmark Pharmaceuticals Inc., USA or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- January 7, 2026
- Recall started
- December 30, 2025
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Ondansetron Orally Disintegrating Tablets, USP, 4mg recalled?+
According to the FDA: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark,…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Ondansetron Orally Disintegrating Tablets, USP, 4mg?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0246-2026. Information last synced from the FDA on July 5, 2026.