Medications & Supplements/Prescription Drugs

Torrent Pantoprazole Sodium Delayed-Release Tablets Recalled for Cracking

Agency Publication Date: May 5, 2022

Summary

Torrent Pharma Inc. is recalling 24,888 bottles of Pantoprazole Sodium (pantoprazole) Delayed-Release Tablets, 20 mg, because the tablets may crack. The recall affects 90-count bottles sold nationwide at pharmacies. The company initiated the recall after discovering manufacturing deviations that resulted in the physical cracking of the tablets.

Risk

Cracked tablets may cause the medication to break down prematurely in the stomach instead of the intestines, potentially reducing the drug's effectiveness. No incidents or injuries have been reported in connection with this recall.

What You Should Do

This recall affects 90-count bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg (NDC 13668-096-90), with lot numbers BA34G021 or BA34G022 and an expiration date of 09/2022.
Check the bottle label for the NDC number (13668-096-90) and the lot number and expiration date to determine if your medication is part of the recall.
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 Torrent Pharma Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information.

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 Delayed-Release Tablets, USP, 20 mg (90-count bottle)

Variants: 20 mg, Delayed-Release Tablet, 90 tablets per bottle

Lot Numbers:

BA34G021 (Exp. 09/2022)

BA34G022 (Exp. 09/2022)

NDC:

13668-096-90

Quantity: 24,888 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89992

Status: Resolved

Manufacturer: Torrent Pharma Inc

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 24,888 bottles

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 90-count bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg (NDC 13668-096-90), with lot numbers BA34G021 or BA34G022 and an expiration date of 09/2022.

Check the bottle label for the NDC number (13668-096-90) and the lot number and expiration date to determine if your medication is part of the recall.

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 Torrent Pharma Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information.