# FDA recall D-1242-2019

> **Zydus Pharmaceuticals USA Inc** · Class III · drug recall initiated 2019-04-22.

## Product

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05

## Reason for recall

Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1242-2019
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-22
- **Report date:** 2019-05-01
- **Termination date:** 2021-01-14

- **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-1242-2019

## Citation

> AI Analytics. FDA recall D-1242-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1242-2019. Source: US FDA. Licensed CC0.

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