July 2025 FDA Recall Cinacalcet by Strides Pharma, Inc.
D-0546-2025 - Failed Dissolution Specifications.
This Class II drug recall was voluntarily initiated by Strides Pharma, Inc. on July 9, 2025 for the product Cinacalcet. The FDA reported the reason for recall as failed dissolution specifications.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0546-2025
Failed Dissolution Specifications.
07-09-2025
08-06-2025
6,672 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Strides Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 7715893A, Exp. Date 12/31/2027
