# FDA recall D-1461-2016

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2016-07-19.

## Product

Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by :  Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.

## Reason for recall

Failed Dissolution Specifications: out of specification dissolution results in retained samples

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1461-2016
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-07-19
- **Report date:** 2016-08-24
- **Termination date:** 2020-09-21

- **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-1461-2016

## Citation

> AI Analytics. FDA recall D-1461-2016. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-1461-2016. Source: US FDA. Licensed CC0.

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