# FDA recall D-0535-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2024-05-13.

## Product

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06

## Reason for recall

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0535-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-13
- **Report date:** 2024-06-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0535-2024

## Citation

> AI Analytics. FDA recall D-0535-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0535-2024. Source: US FDA. Licensed CC0.

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