Reported Nov 6, 2024 · Ongoing

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India,…

Dr. Reddy's Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

  • 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 codes and dates

6 of 6 products

Products covered by this recall
#Product as published
1Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024
2T2200695, T2200694, T2200696, T2200697, Exp 01/2025
3T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025
4T2202743, T2202742, T2202741, & T2202740, Exp 06/2025
5T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025
6T2300770, 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
Amount recalled
285126 bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:08 PM UTC

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