# FDA recall D-0546-2025

> **Strides Pharma, Inc.** · Class II · drug recall initiated 2025-07-09.

## Product

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

## Reason for recall

Failed Dissolution Specifications.

## Distribution

Product was distributed nationwide within the United States

## Key facts

- **Recall number:** D-0546-2025
- **Recalling firm:** Strides Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-09
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chestnut Ridge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0546-2025

## Citation

> AI Analytics. FDA recall D-0546-2025. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/D-0546-2025. Source: US FDA. Licensed CC0.

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