FDAClass IIAugust 6, 2025

Cinacalcet Tablets 90 mg recall: Failed Dissolution

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

Why was Cinacalcet Tablets 90 mg recalled?

Failed Dissolution Specifications.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 7715893A, Exp. Date 12/31/2027

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 firm
Strides Pharma, Inc.
Quantity
6,672 bottles
Distribution
Product was distributed nationwide within the United States
Recall date
August 6, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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