FDA Recall D-0027-2025
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class II Ongoing 582 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Reason for recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall record
- Recall number
D-0027-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide.
- Recall initiated
- 2024-10-09
- Classified by FDA Center
- 2024-10-28
- FDA published
- 2024-11-06
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- CINACALCET
- Generic name(s)
- CINACALCET
- Manufacturer(s)
- Dr. Reddys Laboratories Inc
- NDC(s)
43598-367, 43598-368, 43598-369- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.