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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cipla Cinacalcet Hydrochloride Tablets Recalled for Excessive Impurities

Agency Publication Date: April 10, 2026
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Summary

Cipla USA, Inc. is recalling approximately 272,624 bottles of Cinacalcet Hydrochloride (generic Sensipar) tablets in 30 mg, 60 mg, and 90 mg strengths. The recall was initiated because testing detected the presence of N-Nitroso Cinacalcet, a chemical impurity, at levels above the acceptable daily intake limit. While no injuries or adverse events have been reported to date, the product was distributed nationwide to pharmacies and wholesalers.

Risk

The tablets contain N-Nitroso Cinacalcet at levels that exceed safety limits set by the FDA. Long-term exposure to this impurity above acceptable levels may increase the risk of cancer.

What You Should Do

  1. Check your prescription bottle for Cinacalcet Hydrochloride Tablets in 30 mg, 60 mg, or 90 mg strengths with NDC codes 69097-410-02, 69097-411-02, or 69097-412-02.
  2. Verify if your bottle matches one of the affected lot numbers, including 4PB0526, 4PB0527, 4PB0528, 5PB0173, 4PB0215, 4PB0216, 4PB0515, 4PB0516, 4PB0517, 5PB0167, 4PB0224, 4PB0505, 4PB0506, 4PB0507, or 5PB0564. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cinacalcet Hydrochloride Tablets, 30 mg (30-count bottle)
Variants: 30 mg, Tablet
Lot Numbers:
4PB0526 (Exp 09/2026)
4PB0527 (Exp 09/2026)
4PB0528 (Exp 09/2026)
5PB0173 (Exp 01/2027)
NDC:
69097-410-02

Manufactured by Cipla Ltd., MIDC, Patalganga, India.

Product: Cinacalcet Hydrochloride Tablets, 60 mg (30-count bottle)
Variants: 60 mg, Tablet
Lot Numbers:
4PB0215 (Exp 03/2026)
4PB0216 (Exp 03/2026)
4PB0515 (Exp 09/2026)
4PB0516 (Exp 09/2026)
4PB0517 (Exp 09/2026)
5PB0167 (Exp 01/2027)
NDC:
69097-411-02

Manufactured by Cipla Ltd., MIDC, Patalganga, India.

Product: Cinacalcet Hydrochloride Tablets, 90 mg (30-count bottle)
Variants: 90 mg, Tablet
Lot Numbers:
4PB0224 (Exp 03/2026)
4PB0505 (Exp 09/2026)
4PB0506 (Exp 09/2026)
4PB0507 (Exp 09/2026)
5PB0564 (Exp 04/2027)
NDC:
69097-412-02

Manufactured by Cipla Ltd., MIDC, Patalganga, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98670
Status: Active
Manufacturer: Cipla USA, Inc.
Sold By: Pharmacies nationwide
Manufactured In: India, United States
Units Affected: 272,624
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.