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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Hetero Labs Limited Unit V: Montelukast Sodium 10mg Tablets Recalled for Discoloration (Blue Specks)

Agency Publication Date: September 26, 2018
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Summary

Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium (the generic equivalent of Singulair), 10 mg tablets, due to reports of discoloration. A pharmacist reported finding blue specks on the tablets, which is not an expected characteristic of the medication. This nationwide recall affects 30-count bottles manufactured in India for Camber Pharmaceuticals, Inc. Consumers should contact their healthcare provider or pharmacist regarding the continued use of this medication and for replacement instructions.

Risk

The presence of blue specks indicates a quality defect or potential contamination during the manufacturing process. Consuming tablets with unknown discoloration or foreign particles could lead to unpredictable side effects or reduced medication efficacy.

What You Should Do

  1. Check your medication bottle for the product name 'Montelukast Sodium Tablets, 10 mg' in 30-count bottles.
  2. Verify if your medication is affected by checking for NDC 31722-726-30, Lot Number MON17355, and an expiration date of 12/19 (December 2019).
  3. If your tablets have the affected lot number or if you see blue specks on the tablets, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement.
  4. Return any unused portion of the affected medication to your pharmacy for a refund and contact Hetero Labs Limited or Camber Pharmaceuticals for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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 bottles)
Model:
NDC 31722-726-30
Recall #: D-1213-2018
Lot Numbers:
MON17355 (Exp 12/19)
Date Ranges: Expiration 12/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81029
Status: Resolved
Manufacturer: Hetero Labs Limited Unit V
Sold By: pharmacies nationwide; Camber Pharmaceuticals, Inc.
Manufactured In: India
Units Affected: 98,016 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 ยท 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.