Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle

Cipla USA, Inc. has recalled Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 17, 2025 and was initiated on November 14, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, with approximately 15,744 bottles affected. The company behind the recall is Cipla USA, Inc., based in Warren, NJ. The FDA describes the product as: “Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02”

Why was Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle recalled?

According to the FDA, the stated reason for the recall is: “CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).

CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.

What should you do?

If you think you may have bought Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, compare it against the product description and identifying codes (Lot 5PB0164, exp 1/31/2027) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Cipla USA, Inc. or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.