Recalls / Class II
Class IID-0026-2025
Product
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Active ingredient
- Cinacalcet Hydrochloride
- Route
- Oral
- NDCs
- 43598-367, 43598-368, 43598-369
- FDA application
- ANDA208368
- Affected lot / code info
- Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025 Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026 Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026 Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 11/2026
Why it was recalled
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddys Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 285126 bottles
- Distribution pattern
- USA Nationwide.
Timeline
- Recall initiated
- 2024-10-09
- FDA classified
- 2024-10-28
- Posted by FDA
- 2024-11-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0026-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.