Why it was recalled
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product description
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
Lot numbers, UPCs & expiration codes
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
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0026-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 9, 2024
- FDA report date
- Nov 6, 2024
- Quantity
- 285126 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0026-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95500
- Address
- 107 College Rd E
- Code information
- 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
- Postal code
- 08540-6623
- Report date
- Nov 6, 2024
- Product type
- Drugs
- Recall number
- D-0026-2025
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 285126 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Oct 9, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2024