Medications & Supplements/Prescription Drugs

Jubilant Cadista Pharmaceuticals, Inc.: Pantoprazole Sodium Delayed Release Tablets Recalled for Tablet Discoloration

Agency Publication Date: October 17, 2019

Summary

Approximately 63,216 bottles of Pantoprazole Sodium (generic Protonix) Delayed Release Tablets, USP, 40 mg are being recalled because some tablets show dark brown discoloration on their edges. This discoloration is a deviation from manufacturing quality standards and may affect the medication's consistency. The prescription tablets were sold in 90-count bottles and distributed to wholesalers and distributors in several states and Puerto Rico.

Risk

The dark brown discoloration on the edges of the tablets indicates a quality defect that could potentially impact the medication's stability or effectiveness. Ingesting discolored medication may not provide the intended treatment for acid-related stomach conditions.

What You Should Do

Check your prescription bottle to see if you have Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg in a 90-count bottle with NDC 59746-284-90.
Locate the lot number and expiration date on the side of the label. This recall specifically affects lot numbers PA218P008 and PA218P009 with an expiration date of 04/2021.
If your bottle matches these lot numbers, inspect the tablets for any dark brown discoloration on the edges.
Contact your healthcare provider or pharmacist immediately to discuss if you should continue your treatment or if you need a replacement prescription.
Return any unused tablets from the affected lots to your pharmacy for a refund and contact Jubilant Cadista Pharmaceuticals, Inc. for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return unused product to the pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg (90-count bottle)

Model:

NDC 59746-284-90

Recall #: D-0145-2020

Lot Numbers:

PA218P008 (Exp 04/2021)

PA218P009 (Exp 04/2021)

Date Ranges: Expiration date 04/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83705

Status: Resolved

Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.

Sold By: distributors; wholesalers; pharmacies

Manufactured In: India, United States

Units Affected: 63,216 bottles

Distributed To: Mississippi, Ohio, Rhode Island, Tennessee, Puerto Rico

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

Check your prescription bottle to see if you have Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg in a 90-count bottle with NDC 59746-284-90.

Locate the lot number and expiration date on the side of the label. This recall specifically affects lot numbers PA218P008 and PA218P009 with an expiration date of 04/2021.

If your bottle matches these lot numbers, inspect the tablets for any dark brown discoloration on the edges.

Contact your healthcare provider or pharmacist immediately to discuss if you should continue your treatment or if you need a replacement prescription.

Return any unused tablets from the affected lots to your pharmacy for a refund and contact Jubilant Cadista Pharmaceuticals, Inc. for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.