Cinacalcet Tablets 30 mg Recall: Failed Dissolution
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Cinacalcet Tablets 30 mg recalled?
Failed dissolution specifications
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04
Which lot codes, UPCs or models are affected?
Lot # 7717825A, Expiry: 11/30/2028.
- Agency record number
- D-0079-2027
- Product
- Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04
- Recalling firm
- STRIDES PHARMA INC
- Quantity
- 49,488 30-count bottles
- Distribution
- US Nationwide
- Recall started
- October 7, 2026
- Report date
- October 28, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)