Medications & Supplements/Prescription Drugs

Hetero Labs Limited Unit V: Montelukast Sodium 10 mg Recalled for Potential Label Mix-Up with Losartan

Agency Publication Date: October 17, 2018

Summary

Approximately 98,016 bottles of Montelukast Sodium 10 mg tablets (the generic version of Singulair) are being recalled because some bottles labeled as having 30 tablets of Montelukast may actually contain 90 tablets of Losartan Potassium 50 mg. This mix-up occurred in a single lot of medication manufactured by Hetero Labs Limited and distributed for Camber Pharmaceuticals. Consumers may inadvertently take a blood pressure medication instead of their intended asthma or allergy treatment.

Risk

Taking Losartan Potassium when it is not prescribed, especially at an incorrect dose, can cause dangerously low blood pressure or serious adverse reactions. Additionally, missing a scheduled dose of Montelukast could lead to a worsening of asthma or allergy symptoms.

What You Should Do

Check your prescription bottle for Montelukast Sodium Tablets 10 mg (30-count bottle) with NDC number 31722-726-30.
Verify the lot number and expiration date on the side of the bottle; the affected lot is MON17384 with an expiration date of 12/19.
If your bottle matches this lot number, immediately contact your healthcare provider or pharmacist to confirm if you have the correct medication and to obtain a replacement.
Return any unused product from the affected lot to your pharmacy for a refund and further instructions.
Contact the manufacturer, Camber Pharmaceuticals, for additional information or questions regarding this recall.
For further assistance, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Montelukast Sodium Tablets 10 mg (30-count bottle)

Model:

NDC 31722-726-30

Lot Numbers:

MON17384 (Exp 12/19)

Date Ranges: Exp 12/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80803

Status: Active

Manufacturer: Hetero Labs Limited Unit V

Sold By: Camber Pharmaceuticals, Inc.; Pharmacies

Manufactured In: India

Units Affected: 98016 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 prescription bottle for Montelukast Sodium Tablets 10 mg (30-count bottle) with NDC number 31722-726-30.

Verify the lot number and expiration date on the side of the bottle; the affected lot is MON17384 with an expiration date of 12/19.

If your bottle matches this lot number, immediately contact your healthcare provider or pharmacist to confirm if you have the correct medication and to obtain a replacement.

Return any unused product from the affected lot to your pharmacy for a refund and further instructions.

Contact the manufacturer, Camber Pharmaceuticals, for additional information or questions regarding this recall.

For further assistance, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.