Medications & Supplements/Prescription Drugs

Aurobindo Cinacalcet Tablets Recalled for Excessive Impurity Level

Agency Publication Date: November 29, 2024

Summary

Aurobindo Pharma USA Inc. is recalling 105,912 bottles of Cinacalcet Tablets (30 mg, 60 mg, and 90 mg) because they contain an impurity called N-nitroso Cinacalcet at levels that exceed the FDA's recommended interim limits. This prescription medication is used to treat secondary hyperparathyroidism in patients with kidney disease or high calcium levels in patients with parathyroid cancer. The recall covers 30-count and 500-count HDPE bottles manufactured in India and distributed nationwide.

Risk

N-nitroso Cinacalcet is a type of nitrosamine impurity. Long-term exposure to these impurities above certain levels may increase the risk of cancer, though no specific adverse events or injuries related to this recall have been reported in the data.

What You Should Do

This recall affects Cinacalcet Tablets in 30 mg, 60 mg, and 90 mg strengths sold in 30-count and 500-count HDPE bottles distributed by Aurobindo Pharma USA, Inc.
Check your medication for the following NDC numbers: 65862-831-30, 65862-831-05 (30 mg); 65862-832-30, 65862-832-05 (60 mg); or 65862-833-30, 65862-833-05 (90 mg).
Verify the lot numbers on your bottle. Affected lots include CFSA23001A through CFSA23005A, CFSB23001A through CFSB23004A, CFSC23001A, CFSC23001B, and several 'P' series lots. See the Affected Products section below for the full list of affected codes.
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 Tablets (30 mg)

Variants: 30 mg, Tablet

Lot Numbers:

CFSA23001A (Exp 03/31/2025)

CFSA23002A (Exp 03/31/2025)

CFSA23003A (Exp 03/31/2025)

CFSA23004A (Exp 07/31/2025)

CFSA23005A (Exp 10/31/2025)

P2300191 (Exp 12/31/2024)

P2300192 (Exp 12/31/2024)

P2300193 (Exp 12/31/2024)

P2300194 (Exp 12/31/2024)

NDC:

65862-831-30

65862-831-05

Packaged in 30-count and 500-count HDPE bottles.

Product: Cinacalcet Tablets (60 mg)

Variants: 60 mg, Tablet

Lot Numbers:

CFSB23001A (Exp 03/31/2025)

CFSB23002A (Exp 07/31/2025)

CFSB23003A (Exp 10/31/2025)

CFSB23004A (Exp 10/31/2025)

P2300196 (Exp 12/31/2024)

NDC:

65862-832-30

65862-832-05

Packaged in 30-count and 500-count HDPE bottles.

Product: Cinacalcet Tablets (90 mg)

Variants: 90 mg, Tablet

Lot Numbers:

CFSC23001A (Exp 03/31/2025)

CFSC23001B (Exp 03/31/2025)

P2300195 (Exp 12/31/2024)

NDC:

65862-833-30

65862-833-05

Packaged in 30-count and 500-count HDPE bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95730

Status: Active

Manufacturer: Aurobindo Pharma USA Inc

Sold By: Retail Pharmacies; Wholesale Distributors

Manufactured In: India

Units Affected: 2 products (102576 bottles; 3336 bottles)

Distributed To: Nationwide

Agency Last Updated: December 3, 2024

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

This recall affects Cinacalcet Tablets in 30 mg, 60 mg, and 90 mg strengths sold in 30-count and 500-count HDPE bottles distributed by Aurobindo Pharma USA, Inc.

Check your medication for the following NDC numbers: 65862-831-30, 65862-831-05 (30 mg); 65862-832-30, 65862-832-05 (60 mg); or 65862-833-30, 65862-833-05 (90 mg).

Verify the lot numbers on your bottle. Affected lots include CFSA23001A through CFSA23005A, CFSB23001A through CFSB23004A, CFSC23001A, CFSC23001B, and several 'P' series lots. See the Affected Products section below for the full list of affected codes.

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 Tablets (30 mg)

Variants: 30 mg, Tablet

Lot Numbers:

CFSA23001A (Exp 03/31/2025)

CFSA23002A (Exp 03/31/2025)

CFSA23003A (Exp 03/31/2025)

CFSA23004A (Exp 07/31/2025)

CFSA23005A (Exp 10/31/2025)

P2300191 (Exp 12/31/2024)

P2300192 (Exp 12/31/2024)

P2300193 (Exp 12/31/2024)

P2300194 (Exp 12/31/2024)

NDC:

65862-831-30

65862-831-05

Packaged in 30-count and 500-count HDPE bottles.

Product: Cinacalcet Tablets (60 mg)

Variants: 60 mg, Tablet

Lot Numbers:

CFSB23001A (Exp 03/31/2025)

CFSB23002A (Exp 07/31/2025)

CFSB23003A (Exp 10/31/2025)

CFSB23004A (Exp 10/31/2025)

P2300196 (Exp 12/31/2024)

NDC:

65862-832-30

65862-832-05

Packaged in 30-count and 500-count HDPE bottles.

Product: Cinacalcet Tablets (90 mg)

Variants: 90 mg, Tablet

Lot Numbers:

CFSC23001A (Exp 03/31/2025)

CFSC23001B (Exp 03/31/2025)

P2300195 (Exp 12/31/2024)

NDC:

65862-833-30

65862-833-05

Packaged in 30-count and 500-count HDPE bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95730

Status: Active

Manufacturer: Aurobindo Pharma USA Inc

Sold By: Retail Pharmacies; Wholesale Distributors

Manufactured In: India

Units Affected: 2 products (102576 bottles; 3336 bottles)

Distributed To: Nationwide

Agency Last Updated: December 3, 2024