Medications & Supplements/Prescription Drugs

Dr. Reddy's Montelukast Sodium Tablets Recalled for Wrong Medication

Agency Publication Date: November 3, 2023

Summary

Dr. Reddy's Laboratories, Inc. is recalling 1,656 bottles of Montelukast Sodium (montelukast), an asthma and allergy medication. The recall began after a foreign tablet identified as metoprolol, a blood pressure medication, was found inside a bottle of montelukast. These prescription 1000-count bottles were distributed nationwide to pharmacies and healthcare providers. No injuries have been reported to date.

Risk

Taking metoprolol instead of the intended montelukast could lead to serious medical complications, including dangerously low blood pressure or a slowed heart rate. Consumers who accidentally ingest the wrong medication may experience dizziness, fatigue, or fainting.

What You Should Do

This recall involves 1000-count bottles of Montelukast Sodium Tablets, USP 10 mg, with NDC 55111-725-10.
Identify if your medication is affected by checking the prescription bottle for lot number C2305569 with an expiration date of 03/31/2026.
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 Dr. Reddy's Laboratories, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

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: Montelukast Sodium Tablets, USP 10 mg (1000 count bottle)

Variants: 10 mg, Tablet

Lot Numbers:

C2305569 (Exp. date 03/31/2026)

NDC:

55111-725-10

Distributed by: Dr. Reddy's Laboratories, Princeton, NJ 08540.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93225

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 1,656 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 involves 1000-count bottles of Montelukast Sodium Tablets, USP 10 mg, with NDC 55111-725-10.

Identify if your medication is affected by checking the prescription bottle for lot number C2305569 with an expiration date of 03/31/2026.

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 Dr. Reddy's Laboratories, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.