# FDA recall D-0246-2026

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2025-12-30.

## 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

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0246-2026
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-12-30
- **Report date:** 2026-01-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elmwood Park, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2026

## Citation

> AI Analytics. FDA recall D-0246-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0246-2026. Source: US FDA. Licensed CC0.

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