drugs MODERATE Updated 2026-07-08

Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx

See all recalls from Cipla USA, Inc. →

Recalled Product

Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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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Hazard / Issue

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027

✅ 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