# FDA recall D-0386-2022

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2022-01-04.

## Product

Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0386-2022
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-04
- **Report date:** 2022-01-26
- **Termination date:** 2023-10-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2022

## Citation

> AI Analytics. FDA recall D-0386-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0386-2022. Source: US FDA. Licensed CC0.

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