Class II U.S. Food and Drug Administration

Glenmark Pharmaceuticals Inc., USA Ondansetron Orally Disintegrating Tablets recall: Defective container: Preferred Pharmaceuticals received a letter

Recall published 10 months ago

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.

The hazard: Fall or tip-over hazard

This product can tip over or collapse, which is a hazard that reveals itself all at once rather than gradually.

What the notice says: 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.

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0246-2026
Published
January 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Glenmark Pharmaceuticals Inc., USA
Product type
Prescription & OTC drugs
Units affected
96,948 packs
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 19251311, Exp Date April 2027

Products covered by this recall

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

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 19251311
  • 948 packs

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • April 2027 — 96
  • 948 packs

NDC number

On the carton and again on the bottle or blister label.

  • 68462-157-13

Model or item number

On the rating label, the box or the instruction sheet.

  • NDC 68462-157-13 — Lot

Package size

Match the net weight or the piece count on the front of the pack.

  • 4 mg
  • 948 packs

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fall

Glenmark Pharmaceuticals Inc., USA — This product can tip over or collapse, which is a hazard that reveals itself all at once rather than gradually.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.
  3. Follow the remedy on this page; many of these recalls supply a free anchoring kit as well as a refund.
  4. Anchor tall furniture to the wall with a tip-over restraint — this is worth doing for every chest and bookcase in the house, not just this one.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.

Company contact: Glenmark Pharmaceuticals Inc., USA — 619 River Dr, Elmwood Park, NJ, 07407-1317

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Glenmark Pharmaceuticals Inc., USA prescription & otc drugs 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 19251311, 948 packs; best-by date April 2027 — 96 or 948 packs; model number NDC 68462-157-13 — Lot. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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