# FDA recall D-182-2013

> **Glenmark Generics Inc., USA** · Class III · drug recall initiated 2013-02-13.

## 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).

## Distribution

Nationwide

## Key facts

- **Recall number:** D-182-2013
- **Recalling firm:** Glenmark Generics Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-13
- **Report date:** 2013-03-13
- **Termination date:** 2014-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-182-2013

## Citation

> AI Analytics. FDA recall D-182-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-182-2013. Source: US FDA. Licensed CC0.

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