FDA Drug recall D-0920-2017
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
- FDA Drug
- Class III
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class III recall of Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93 by Mylan Pharmaceuticals, citing failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0920-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-05-09 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Reason
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Identifiers
| code_info | Batch 3074707, exp 02/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Mylan Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0920-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.