FDA Recall D-0246-2026

Glenmark Pharmaceuticals Inc., USA · Elmwood Park, NJ

Class II Ongoing 135 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: 19251311, Exp Date April 2027

Quantity: 96,948 packs

Reason for recall

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.

Recall record

Recall number: D-0246-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2025-12-30
Classified by FDA Center: 2025-12-31
FDA published: 2026-01-07
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Elmwood Park, NJ

Drug identification

Brand name(s): ONDANSETRON
Generic name(s): ONDANSETRON
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-105, 68462-106, 68462-157, 68462-158
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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