Mylan Pharmaceuticals Montelukast Sodium Oral Granules Recall

Why it was recalled

Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities

Product description

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

Lot numbers, UPCs & expiration codes

Batch 3074707, exp 02/2018

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0920-2017
Classification: Class III
Status: Terminated
Recall initiated: May 9, 2017
FDA report date: Jun 21, 2017
Quantity: 11,624 pouches
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0920-2017, exactly as published.

Show all FDA fields

City: Morgantown
State: WV
Status: Terminated
Country: United States
Event ID: 77430
Address: 781 Chestnut Ridge Rd
Code information: Batch 3074707, exp 02/2018
Postal code: 26505-2730
Report date: Jun 21, 2017
Product type: Drugs
Recall number: D-0920-2017
Classification: Class III
Recalling firm: Mylan Pharmaceuticals Inc.
Product quantity: 11,624 pouches
Termination date: Feb 14, 2018
Reason for recall: Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Voluntary / mandated: Voluntary: Firm initiated
Product description: Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Distribution pattern: Nationwide
Recall initiation date: May 9, 2017
Initial firm notification: Letter
Center classification date: Jun 15, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0920-2017, published Jun 21, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.