FDA recall D-0546-2025

Strides Pharma, Inc. · Class II · drug

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

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

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