Hetero Montelukast Tablets Recall: Blue Spots in Bottles
Hetero USA recalls 10mg Monteluk: blue spots on tablets or powder in bottle. Stop using if you have this product.
Lower-risk recall
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Contact the company
What happened, in plain English
Hetero USA is recalling Montelukast sodium tablets (10 mg, 30-count) due to blue spots on tablets or blue powder inside the bottle. This could be a sign of contamination that might affect safety. Read more at govinfonow.com/recall/42093-hetero-montelukast-tablets-recall-blue-spots-in-bottles.
Source Summary by GovInfoNow · govinfonow.com/recall/42093-hetero-montelukast-tablets-recall-blue-spots-in-bottles · Updated October 8, 2026 · FDA enforcement record: FDA #D-0623-2017
Cite this page
“Hetero Montelukast Tablets Recall: Blue Spots in Bottles.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42093-hetero-montelukast-tablets-recall-blue-spots-in-bottles. Based on FDA recall #D-0623-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0623-2017%22&limit=1).
Why it’s dangerous
The recall is for blue spots on tablets or blue powder inside the bottle. This could indicate contamination that might affect safety, but the hazard is not described as causing serious injury.
Who’s affected
People with a prescription for Montelukast sodium tablets (10 mg, 30-count) from Hetero USA. Those with the product are most at risk.
How to tell if you have this one
Check for blue spots on tablets or blue powder inside the bottle. The product is a 10 mg Montelukast sodium tablets, 30-count bottle, Rx Only, manufactured for Camber Pharmaceuticals, Inc.
- Brand
Hetero USA- Category
Drug
What to do — step by step
Check for Blue Spots
Look for blue spots on the tablets or blue powder inside the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall is due to potential contamination indicated by blue spots or blue powder. The product is not safe to use if these signs are present.
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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-0623-2017 (January 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0623-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.