drugs MODERATE Updated 2026-04-22

Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bott

See all recalls from Cipla USA, Inc. →

Recalled Product

Cinacalcet Hydrochloride Tablets, 60 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: 69097-411-02

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Hazard / Issue

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall