Medications & Supplements/Prescription Drugs

Lupin Desloratadine Tablets Recalled for Excessive Impurity Levels

Agency Publication Date: January 10, 2024

Summary

Lupin Pharmaceuticals Inc. has recalled Desloratadine Tablets USP (5mg), an antihistamine used to treat allergy symptoms, because a specific impurity (N-Nitroso Desloratadine) was found at levels higher than the acceptable daily intake limit. The recall affects approximately 32,106 bottles distributed nationwide in both 100-count and 500-count containers. No injuries or adverse events have been reported in connection with this recall.

Risk

The tablets contain elevated levels of N-Nitroso Desloratadine. Long-term exposure to this impurity above acceptable safety limits may increase the risk of cancer.

What You Should Do

This recall affects Desloratadine Tablets USP (5mg) sold in 100-count bottles (NDC 68180-153-01) and 500-count bottles (NDC 68180-153-02) manufactured for Lupin Pharmaceuticals, Inc.
Check your bottle for lot numbers G201822, G201823, or G201824, all of which have an expiration date of January 2024.
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 Lupin Pharmaceuticals Inc. 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: Desloratadine Tablets USP (5mg)

Variants: 5 mg, 100 count bottle, 500 count bottle

Lot Numbers:

G201822 (Exp Jan 2024)

G201823 (Exp Jan 2024)

G201824 (Exp Jan 2024)

NDC:

68180-153-01

68180-153-02

Quantity includes 29,184 of the 100-count bottles and 2,922 of the 500-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93669

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies nationwide

Manufactured In: United States

Units Affected: 100=29,184 bottles; 500=2922 bottles

Distributed To: Nationwide

Agency Last Updated: January 19, 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 Desloratadine Tablets USP (5mg) sold in 100-count bottles (NDC 68180-153-01) and 500-count bottles (NDC 68180-153-02) manufactured for Lupin Pharmaceuticals, Inc.

Check your bottle for lot numbers G201822, G201823, or G201824, all of which have an expiration date of January 2024.

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 Lupin Pharmaceuticals Inc. for further instructions.

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