Class IIOngoing

Cinacalcet Tablets 90 mg recall

FDA recall D-0546-2025 · initiated Jul 9, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Dissolution Specifications.

Details

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
Recalling company: Strides Pharma Intl
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Product was distributed nationwide within the United States
Initiated: Jul 9, 2025
FDA report date: Aug 6, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0546-2025 ↗

← All drug recalls