Recall archive / FDA drug enforcement
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Prefer... — FDA record D-0239-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- 575 1x10 Foil Blister Packs
- Agency-reported status
- Ongoing
- Source record identifier
- D-0239-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: J1325J, I1725P, EXP Date: 4/30/2027. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Natinowide in the USA
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 24, 2025
- Recall initiation date
- Nov 17, 2025
- Center classification date
- Dec 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.