FDA Drug · D-0546-2025

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

Class II · Ongoing

Failed Dissolution Specifications.

Affected lots / codes — check yours against thisLot #: 7715893A, Exp. Date 12/31/2027

Recalling firm: Strides Pharma, Inc., Chestnut Ridge, NY
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 6,672 bottles
Distribution: Product was distributed nationwide within the United States
Recall initiated: July 9, 2025
Classified: July 30, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0546-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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