Class III · Lower riskRecall completed
Montelukast Sodium Oral Granules
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberBatch 3074707, exp 02/2018
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Mylan Pharmaceuticals Inc. |
| NDC | 0378-6040-93 |
Show the full FDA record
| Full product label | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Distribution | Nationwide |
| Quantity | 11,624 pouches |
| Recall initiated | 2017-05-09 |
| Report date | 2017-06-21 |
| Recall completed | 2018-02-14 |
| Recall number | D-0920-2017 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Morgantown WV United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.