Cinacalcet Hydrochloride Tablets recalled over manufacturing violations
- Recall date
- March 16, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,…
- Recall number
- D-0449-2026
- FDA classification
- Class II
- Brand / firm
- Cipla USA, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
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