FDA Recall D-0239-2026

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Class II Ongoing 178 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 ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

Lot / code: Lot: J1325J, I1725P, EXP Date: 4/30/2027.

Quantity: 575 1x10 Foil Blister 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-0239-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Natinowide in the USA
Recall initiated: 2025-11-17
Classified by FDA Center: 2025-12-17
FDA published: 2025-12-24
Recalling firm: Preferred Pharmaceuticals, Inc.
Firm location: Anaheim, CA

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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