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 for Delayed-Release Oral Suspension*40 mg* suspension in apple Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Discoloration

Date: July 25, 2022
Company: SUN PHARMACEUTICAL INDUSTRIES 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 SUN PHARMACEUTICAL INDUSTRIES INC directly.

Affected Products

Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60

Quantity: 14, 064 (30 sachets in a carton)

Why Was This Recalled?

Discoloration

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.

Related Recalls

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