D-0079-2027 Class II Ongoing
FDA drug recall D-0079-2027 was initiated by STRIDES PHARMA INC on Oct 7, 2026 and is designated Class II. Reason for recall: Failed dissolution specifications The recall status is ongoing. Affected quantity: 49,488 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 28, 2026
- Initiation Date
- Oct 7, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,488 30-count bottles
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
Reason for Recall
Failed dissolution specifications
Distribution Pattern
US Nationwide
Code Information
Lot # 7717825A, Expiry: 11/30/2028.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0079-2027
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026