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Drug recall · FDA · Published August 15, 2018

Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally,

Hetero Labs recalls Montelukast Sodium 10mg tablets due to potential Losartan Potassium mix-up in one lot. Check your NDC 31722-726-30, lot MON17384, exp 12/19.

🇺🇸 FDA recall #D-0081-2019DrugHetero Labs ›
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Contact the company & request your remedy

Recalling firmHetero Labs Limited Unit VUnit V (SEZ Unit I in APIIC SEZ), Surv. No. 439-441, 458, Polepally Vill. · Jadcherla Mandal, Mahaboob Nagar, N/A
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Hetero Labs is recalling Montelukast Sodium Tablets 10 mg (30-count) because one lot may contain Losartan Potassium 50 mg instead of the intended medication. This mix-up could cause unintended medication effects if taken. Read more at govinfonow.com/recall/39724-hetero-labs-montelukast-tablets-recall-label-mix-up-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39724-hetero-labs-montelukast-tablets-recall-label-mix-up-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0081-2019

Cite this page

“Hetero Labs Montelukast Tablets Recall: Label Mix-Up Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39724-hetero-labs-montelukast-tablets-recall-label-mix-up-risk. Based on FDA recall #D-0081-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0081-2019%22&limit=1).

Why it’s dangerous

The label mix-up means one batch of Montelukast tablets might contain Losartan Potassium 50 mg instead of the intended medication. This could cause unintended medication effects if taken by someone who needs Montelukast.

Who’s affected

People with a prescription for Montelukast Sodium Tablets 10 mg from Hetero Labs (Unit V) in India. Those who received the specific lot number MON17384 (expiring Dec 2019) are most at risk.

How to tell if you have this one

Check for the NDC code 31722-726-30, lot number MON17384, and expiration date 12/19 on the bottle. This product was manufactured for Camber Pharmaceuticals in the US.

  • Brand
    Hetero Labs
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for NDC 31722-726-30, lot MON17384, and expiration date 12/19 on the bottle.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall is for a potential label mix-up that could contain Losartan Potassium 50 mg instead of Montelukast Sodium. This may cause unintended medication effects if taken, but the risk is low.

How do I know if I have the recalled product?

Check for NDC 31722-726-30, lot number MON17384, and expiration date 12/19 on the bottle.

What should I do if I have the recalled product?

The recall does not require immediate action. Check the product label to see if it matches the recalled details.

Take action

Contact Hetero Labs

We’ve drafted a message you can send Hetero Labs to request your refund or repair — edit it as you like.

Subject: Recall D-0081-2019 — Hetero Labs Hetero Labs

Hello,

I own a Hetero Labs that is covered by recall D-0081-2019 from Hetero Labs.

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.

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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-0081-2019 (August 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0081-2019 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA