Medications & Supplements/Prescription Drugs

Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity

Agency Publication Date: December 9, 2025

Summary

Cipla USA, Inc. is voluntarily recalling 91,824 bottles of Cinacalcet Hydrochloride (30 mg, 60 mg, and 90 mg) tablets because testing detected a nitrosamine impurity, N-nitroso-cinacalcet, at levels higher than the acceptable daily limit. This medication is used to treat secondary hyperparathyroidism and high calcium levels. The recall affects specific lots distributed nationwide in the United States between late 2025 and 2027.

Risk

Nitrosamines are impurities that may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

What You Should Do

Check your medication bottle for the following NDC numbers: 69097-410-02 (30 mg), 69097-411-02 (60 mg), or 69097-412-02 (90 mg).
Verify if your bottle matches one of the affected lot numbers: 4PB0109 (Exp 1/31/2026), 5PB0172 (Exp 1/31/2027), 5PB0164 (Exp 1/31/2027), or 5PB0183 (Exp 1/31/2027).
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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 Tablets per bottle)

Variants: 30 mg, Tablet

Lot Numbers:

4PB0109 (exp 1/31/2026)

5PB0172 (exp 1/31/2027)

NDC:

69097-410-02

Recall #: D-0224-2026; Quantity: 63,504 bottles

Product: Cinacalcet Hydrochloride Tablets (60 mg, 30 Tablets per bottle)

Variants: 60 mg, Tablet

Lot Numbers:

5PB0164 (exp 1/31/2027)

NDC:

69097-411-02

Recall #: D-0225-2026; Quantity: 15,744 bottles

Product: Cinacalcet Hydrochloride Tablets (90 mg, 30 Tablets per bottle)

Variants: 90 mg, Tablet

Lot Numbers:

5PB0183 (exp 1/31/2027)

NDC:

69097-412-02

Recall #: D-0226-2026; Quantity: 12,576 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97974

Status: Active

Manufacturer: Cipla USA, Inc.

Sold By: Retail Pharmacies

Manufactured In: United States

Units Affected: 3 products (63,504 bottles; 15,744 bottles; 12,576 bottles)

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 · 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.

Summary

What You Should Do

Check your medication bottle for the following NDC numbers: 69097-410-02 (30 mg), 69097-411-02 (60 mg), or 69097-412-02 (90 mg).

Verify if your bottle matches one of the affected lot numbers: 4PB0109 (Exp 1/31/2026), 5PB0172 (Exp 1/31/2027), 5PB0164 (Exp 1/31/2027), or 5PB0183 (Exp 1/31/2027).

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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 Tablets per bottle)

Variants: 30 mg, Tablet

Lot Numbers:

4PB0109 (exp 1/31/2026)

5PB0172 (exp 1/31/2027)

NDC:

69097-410-02

Recall #: D-0224-2026; Quantity: 63,504 bottles

Product: Cinacalcet Hydrochloride Tablets (60 mg, 30 Tablets per bottle)

Variants: 60 mg, Tablet

Lot Numbers:

5PB0164 (exp 1/31/2027)

NDC:

69097-411-02

Recall #: D-0225-2026; Quantity: 15,744 bottles

Product: Cinacalcet Hydrochloride Tablets (90 mg, 30 Tablets per bottle)

Variants: 90 mg, Tablet

Lot Numbers:

5PB0183 (exp 1/31/2027)

NDC:

69097-412-02

Recall #: D-0226-2026; Quantity: 12,576 bottles