# FDA recall D-0533-2025

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2025-07-09.

## Product

Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

## Reason for recall

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0533-2025
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-09
- **Report date:** 2025-07-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0533-2025

## Citation

> AI Analytics. FDA recall D-0533-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0533-2025. Source: US FDA. Licensed CC0.

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