Medications & Supplements/Prescription Drugs

Slate Run Cinacalcet Hydrochloride Tablets Recalled for Impurity

Agency Publication Date: March 17, 2025

Summary

Slate Run Pharmaceuticals is recalling approximately 59,234 bottles of Cinacalcet Hydrochloride Tablets (30 mg and 60 mg) due to the presence of a nitrosamine impurity. These prescription medications, used to treat certain conditions involving high calcium or parathyroid hormone levels, were found to contain levels of N-nitrosamine that exceed the daily intake limit set by the FDA. The recall affects specific lots of 30-count bottles distributed nationwide to eight major distributors.

Risk

Nitrosamines are common impurities found in water and foods, but exposure to levels above the acceptable daily limit over a long period of time may increase the risk of cancer.

What You Should Do

This recall affects Cinacalcet Hydrochloride Tablets (30 mg and 60 mg) sold in 30-count bottles under the Slate Run Pharmaceuticals brand, manufactured by Piramal Pharma Limited.
For the 30 mg tablets, identify the product by NDC 70436-007-04 and check for lot numbers 07711 (Exp 07/2025), 08900 (Exp 09/2026), or 08899 (Exp 09/2026).
For the 60 mg tablets, identify the product by NDC 70436-008-04 and check for lot number 109797 (Exp 11/2026).
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 Slate Run Pharmaceuticals 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)

Variants: 30 mg, 30-count bottle, Tablet

Lot Numbers:

07711 (Exp 07/2025)

08900 (Exp 09/2026)

08899 (Exp 09/2026)

NDC:

70436-007-04

Distributed by Slate Run Pharma., LLC; Manufactured by Piramal Pharma Limited

Product: Cinacalcet Hydrochloride Tablets (60 mg)

Variants: 60 mg, 30-count bottle, Tablet

Lot Numbers:

109797 (Exp 11/2026)

NDC:

70436-008-04

Distributed by Slate Run Pharma., LLC; Manufactured by Piramal Pharma Limited

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96433

Status: Active

Manufacturer: Slate Run Pharmaceuticals

Sold By: Distributors

Manufactured In: United States, India

Units Affected: 2 products (56,790 bottles; 2,444 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

This recall affects Cinacalcet Hydrochloride Tablets (30 mg and 60 mg) sold in 30-count bottles under the Slate Run Pharmaceuticals brand, manufactured by Piramal Pharma Limited.

For the 30 mg tablets, identify the product by NDC 70436-007-04 and check for lot numbers 07711 (Exp 07/2025), 08900 (Exp 09/2026), or 08899 (Exp 09/2026).

For the 60 mg tablets, identify the product by NDC 70436-008-04 and check for lot number 109797 (Exp 11/2026).

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 Slate Run Pharmaceuticals 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)

Variants: 30 mg, 30-count bottle, Tablet

Lot Numbers:

07711 (Exp 07/2025)

08900 (Exp 09/2026)

08899 (Exp 09/2026)

NDC:

70436-007-04

Distributed by Slate Run Pharma., LLC; Manufactured by Piramal Pharma Limited

Product: Cinacalcet Hydrochloride Tablets (60 mg)

Variants: 60 mg, 30-count bottle, Tablet

Lot Numbers:

109797 (Exp 11/2026)

NDC:

70436-008-04

Distributed by Slate Run Pharma., LLC; Manufactured by Piramal Pharma Limited