Skip to content
Use caution Drug recall · FDA · Published December 30, 2025

Glenmark Ondansetron Tablets Recall: Blister Packs Not Fully Sealed

Glenmark Pharmaceuticals recalls 4mg orally disintegrating ondansetron tablets due to blister packs not fully sealed, risking tablets falling out. Rx-only product sold in 30-tablet blister packs.

🇺🇸 FDA recall #D-0246-2026DrugGlenmark ›
Take action

Contact the company

Recalling firmGlenmark Pharmaceuticals Inc., USA619 River Dr · Elmwood Park, NJ 07407-1317
✎ GovInfoNow plain-language explainer

Glenmark Pharmaceuticals is recalling 4mg ondansetron orally disintegrating tablets because the blister packs may not be fully sealed, causing tablets to fall out. This could lead to accidental ingestion of the medication by others, especially in households with children. Read more at govinfonow.com/recall/31569-glenmark-ondansetron-tablets-recall-blister-packs-not-fully-sealed.

Source Summary by GovInfoNow · govinfonow.com/recall/31569-glenmark-ondansetron-tablets-recall-blister-packs-not-fully-sealed · Updated August 17, 2026 · FDA enforcement record: FDA #D-0246-2026

Cite this page

“Glenmark Ondansetron Tablets Recall: Blister Packs Not Fully Sealed.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31569-glenmark-ondansetron-tablets-recall-blister-packs-not-fully-sealed. Based on FDA recall #D-0246-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0246-2026%22&limit=1).

The FDA announced on Dec. 30, 2025, that Glenmark Pharmaceuticals Inc., USA is recalling Ondansetron Orally Disintegrating Tablets due to defective blister packs that are not fully sealed. The agency said the defect allows tablets to fall out of the packaging.

How to tell if you have it

  • Brand: Glenmark
  • Product: Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets)
  • NDC: 68462-157-13
  • Lot #: 19251311
  • Exp Date: April 2027
  • Quantity: 96,948 packs

The hazard

According to the FDA, Preferred Pharmaceuticals received a letter from manufacturer Glenmark stating that the blister packs are not fully sealed and tablets are falling out. The company purchased the finished product and repackaged it for sale.

Context

GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since 2017-11-20. Other recent recalls of similar products include Glenmark Azelaic Acid Gel 15% Recall (2026-07-23), Glenmark Alyacen Birth Control Tablets Recall (2026-05-27), and Glenmark Bisoprolol/Hydrochlorothiazide Tablets Recall (2025-11-21). Other recent recalls of similar products include Preferred Pharma Recalls Ondansetron ODT Due to Defective Seals (2025-11-17), Oxycodone 5mg Tablets Recall: Weak Blister Seals Cause Tablets to Fall Out (2026-01-14), and Bionpharma Divalproex Tablets Recall: Foreign Tablets Risk (2026-06-26).

How to tell if you have this one

Check for 4mg ondansetron orally disintegrating tablets in 30-tablet blister packs (3 blistercards each with 10 tablets). The product was sold by Preferred Pharmaceuticals after being repackaged from Glenmark Pharmaceuticals.

  • Brand
    Glenmark
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Blister Packs

    Inspect the blister packs for signs of being not fully sealed, such as tablets falling out.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 8 days after the firm started it.

1. Firm started the recall: Dec 30, 202512. FDA classified it Class II: Dec 31, 202523. Published in FDA’s Enforcement Report: Jan 7, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Glenmark recalls

Latest drug recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0246-2026 (December 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0246-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA