Recalls / Class II
Class IID-0239-2026
Product
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
- Affected lot / code info
- Lot: J1325J, I1725P, EXP Date: 4/30/2027.
Why it was 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.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 575 1x10 Foil Blister Packs
- Distribution pattern
- Natinowide in the USA
Timeline
- Recall initiated
- 2025-11-17
- FDA classified
- 2025-12-17
- Posted by FDA
- 2025-12-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0239-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.