Montelukast Sodium Oral Granules — Class III drug recall D-0920-2017
Terminated recall by Mylan Pharmaceuticals Inc., reported 2017-06-21, distributed nationwide. Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total I
| Recall number | D-0920-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2017-05-09 |
| Classified | 2017-06-15 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 11,624 pouches |
| Reason classes | specification failure |
| NDC | 00378-6040-93 |
| Lot numbers | 3074707 |
| Expiration dates | 2018-02 |
Product
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Reason for recall
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0920-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.