Mylan Montelukast Sodium Oral Granules Recall: Impurity Risk
Mylan recalls Montelukast Sodium Oral Granules (4 mg pouch) due to impurity issues. This prescription medication may contain unsafe levels of sulfoxide and total impurities.
Recall notice
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Contact the company
What happened, in plain English
Mylan is recalling prescription Montelukast Sodium Oral Granules (4 mg pouch) because tests found unsafe levels of impurities. This could pose health risks if the medication is taken as directed. Read more at govinfonow.com/recall/41630-mylan-montelukast-sodium-oral-granules-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41630-mylan-montelukast-sodium-oral-granules-recall-impurity-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0920-2017
Cite this page
“Mylan Montelukast Sodium Oral Granules Recall: Impurity Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41630-mylan-montelukast-sodium-oral-granules-recall-impurity-risk. Based on FDA recall #D-0920-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0920-2017%22&limit=1).
Why it’s dangerous
The medication failed quality tests for two specific impurities: sulfoxide and total impurities. These impurities could potentially cause health issues if the medication is taken as intended.
Who’s affected
Prescription medication users who have the specific Montelukast Sodium Oral Granules (4 mg pouch) with NDC 0378-6040-93 and batch 3074707. People taking this medication for asthma or allergies are most at risk.
How to tell if you have this one
Check for the product name 'Montelukast Sodium Oral Granules', 4 mg pouch, prescription-only, with NDC code 0378-6040-93 and batch number 3074707. The expiration date is February 2018.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0378-6040-93 and batch number 3074707 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 9 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.
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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-0920-2017 (May 9, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0920-2017 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.