Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Pantoprazole Oral Suspension Recalled for Discoloration

Agency Publication Date: November 22, 2022

Summary

Sun Pharmaceutical Industries Inc. has recalled 14,064 units (30 sachets per carton) of Pantoprazole Sodium for Delayed-Release Oral Suspension, 40 mg. This prescription medication, which is the generic version of Protonix, is being recalled because the product may show discoloration. If you use this medication, you should consult with your healthcare provider or pharmacist regarding your treatment.

Risk

Discoloration of the oral suspension indicates a quality defect that may impact the drug's stability or effectiveness. While no injuries have been reported, using a degraded medication could lead to ineffective treatment of stomach acid-related conditions.

What You Should Do

This recall affects Sun Pharmaceutical Industries, Inc. Pantoprazole Sodium for Delayed-Release Oral Suspension, 40 mg, sold in cartons containing 30 sachets.
Identify the affected product by checking the packaging for NDC 62756-071-60 and Lot MHC1317A with an expiration date of 07/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pantoprazole Sodium for Delayed-Release Oral Suspension (40 mg)

Variants: 40 mg, Delayed-Release Oral Suspension

Lot Numbers:

MHC1317A (Exp 07/2023)

NDC:

62756-071-60

Distributed in cartons containing 30 sachets; intended for suspension in apple juice or applesauce only.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91146

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: pharmacies; hospitals

Manufactured In: India, United States

Units Affected: 14, 064 (30 sachets in a carton)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Sun Pharmaceutical Industries, Inc. Pantoprazole Sodium for Delayed-Release Oral Suspension, 40 mg, sold in cartons containing 30 sachets.

Identify the affected product by checking the packaging for NDC 62756-071-60 and Lot MHC1317A with an expiration date of 07/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.