# FDA recall D-1504-2016

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2016-06-27.

## Product

Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1504-2016
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-27
- **Report date:** 2016-09-28
- **Termination date:** 2018-03-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1504-2016

## Citation

> AI Analytics. FDA recall D-1504-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1504-2016. Source: US FDA. Licensed CC0.

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