🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: March 16, 2026 Cipla USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cipla USA, Inc.
Reason for Recall:
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0450-2026

Related Recalls

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67

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Class I - Dangerous

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Mar 13, 2026 Prescription Drugs Nationwide View Details →