# FDA recall D-1499-2016

> **Aurobindo Pharma USA Inc** · Class II · drug recall initiated 2016-08-03.

## Product

Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90

## Reason for recall

Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.

## Distribution

CA

## Key facts

- **Recall number:** D-1499-2016
- **Recalling firm:** Aurobindo Pharma USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-03
- **Report date:** 2016-09-21
- **Termination date:** 2018-06-08

- **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-1499-2016

## Citation

> AI Analytics. FDA recall D-1499-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1499-2016. Source: US FDA. Licensed CC0.

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