Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Class II · Ongoing
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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Affected lots / codes — check yours against thisLot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 35880 bottles
- Distribution
- USA Nationwide.
- Recall initiated
- October 9, 2024
- Classified
- October 28, 2024
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0027-2025%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0027-2025%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →