# FDA recall D-0081-2019

> **Hetero Labs Limited Unit V** · Class I · drug recall initiated 2018-08-15.

## Product

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

## Reason for recall

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0081-2019
- **Recalling firm:** Hetero Labs Limited Unit V
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2018-08-15
- **Report date:** 2018-10-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jadcherla Mandal, Mahaboob Nagar, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2019

## Citation

> AI Analytics. FDA recall D-0081-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0081-2019. Source: US FDA. Licensed CC0.

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