Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pantoprazole Sodium Delayed-Release Tablets USP Recalled by Aurobindo Pharma USA Inc Due to Presence of Foreign Tablets/Capsules: Firm received a market...

Date: August 3, 2016
Company: Aurobindo Pharma USA Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aurobindo Pharma USA Inc directly.

Affected Products

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

Quantity: 23016 bottles

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Aurobindo Pharma USA Inc

Aurobindo Pharma USA Inc has 11 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report