Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally,
Hetero Labs Limited recalls 10mg Montelukast Sodium tablets with blue specks. This may affect prescription medication safety. Stop using and contact your pharmacist.
Lower-risk recall
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Contact the company & request your remedy
What happened, in plain English
Hetero Labs Limited is recalling 10 mg Montelukast Sodium tablets that have blue specks. This could be a safety issue for people taking prescription asthma medication. Read more at govinfonow.com/recall/39710-hetero-labs-montelukast-tablets-recalled-due-to-blue-specks.
Source Summary by GovInfoNow · govinfonow.com/recall/39710-hetero-labs-montelukast-tablets-recalled-due-to-blue-specks · Updated October 6, 2026 · FDA enforcement record: FDA #D-1213-2018
Cite this page
“Hetero Labs Montelukast Tablets Recalled Due to Blue Specks.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39710-hetero-labs-montelukast-tablets-recalled-due-to-blue-specks. Based on FDA recall #D-1213-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1213-2018%22&limit=1).
Why it’s dangerous
Blue specks in the tablets could indicate a manufacturing issue. While not harmful in normal use, they might signal a problem with the medication's quality.
Who’s affected
People with a prescription for Montelukast Sodium tablets from Hetero Labs Limited. Those with asthma or allergies may be most at risk.
How to tell if you have this one
Check for 10 mg Montelukast Sodium tablets with blue specks. The product was sold in India by Hetero Labs Limited, Unit V, with NDC 31722-726-30.
- Brand
Hetero Labs Limited- Category
Drug
What to do — step by step
Check for Blue Specks
Look for blue specks on the tablets. If present, stop using the product.
Questions people ask
Is this product dangerous?
The recall is for blue specks, which may indicate a manufacturing issue. The product is not harmful in normal use but should be checked.
How do I know if I have the recalled product?
Check for 10 mg Montelukast Sodium tablets with blue specks. The product was sold in India by Hetero Labs Limited, Unit V, with NDC 31722-726-30.
What should I do if I have the product?
If you see blue specks, stop using the product and contact your pharmacist.
Contact Hetero Labs Limited
We’ve drafted a message you can send Hetero Labs Limited to request your refund or repair — edit it as you like.
Subject: Recall D-1213-2018 — Hetero Labs Limited Hetero Labs Limited Hello, I own a Hetero Labs Limited that is covered by recall D-1213-2018 from Hetero Labs Limited. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1213-2018 (August 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1213-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.