# FDA recall D-0753-2021

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2021-08-13.

## Product

Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05

## Reason for recall

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0753-2021
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-13
- **Report date:** 2021-08-25
- **Termination date:** 2023-04-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0753-2021

## Citation

> AI Analytics. FDA recall D-0753-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0753-2021. Source: US FDA. Licensed CC0.

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