# FDA recall D-0474-2017

> **Aurobindo Pharma USA Inc** · Class II · drug recall initiated 2016-12-22.

## Product

Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30

## Reason for recall

Failed Tablet/Capsule Specifications: Some bottles contain  punctured, and/or clumped/melted capsules.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0474-2017
- **Recalling firm:** Aurobindo Pharma USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-22
- **Report date:** 2017-02-22
- **Termination date:** 2019-03-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2017

## Citation

> AI Analytics. FDA recall D-0474-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0474-2017. Source: US FDA. Licensed CC0.

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