FDAFDA recall D-0079-2027 · Oct 28, 2026
STRIDES PHARMA INC: Cinacalcet Tablets recall
Recall found
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
Reason for recall
Failed dissolution specifications
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # 7717825A, Expiry: 11/30/2028.
- Quantity
- 49,488 30-count bottles
- Distribution
- US Nationwide
- Recalling firm
- STRIDES PHARMA INC, Bridgewater, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-10-07
Source: openFDA enforcement record D-0079-2027 · search recall number D-0079-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Nov 3, 2026, 1:33 AM EST. The agency notice is the final word.