# FDA recall D-0510-2023

> **Teva Pharmaceuticals USA Inc** · Class III · drug recall initiated 2023-03-27.

## Product

Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19

## Reason for recall

Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0510-2023
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-03-27
- **Report date:** 2023-04-12
- **Termination date:** 2023-08-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2023

## Citation

> AI Analytics. FDA recall D-0510-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0510-2023. Source: US FDA. Licensed CC0.

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