Montelukast Sodium Tablets — Class III drug recall D-182-2013
Terminated recall by Glenmark Generics Inc., USA, reported 2013-03-13, distributed nationwide. Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists a
| Recall number | D-182-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Generics Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2013-02-13 |
| Classified | 2013-03-05 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2014-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 591,972 bottles |
| Reason classes | chemical contamination |
| NDC | 68462-0392-30, 68462-0392-90 |
Product
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.
Reason for recall
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
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-182-2013. 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.