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Drug FDA Class II Ongoing cGMP deviation

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

Cipla USA, Inc. Published Dec 17, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Cipla USA, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Hazards

N-nitroso-cinacalcet · primary

Affected products (1)

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

CINACALCET · 15,744 bottles

NDC: 69097-410, 69097-411, 69097-412, 69097-410-02, 69097-411-02, 69097-412-02
Lot codes: 5PB0164
Code info: Lot 5PB0164, exp 1/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 14, 2025
  2. Published
    Dec 17, 2025
Recall number
D-0225-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.