Medications & Supplements/Prescription Drugs

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

Agency Publication Date: October 9, 2018

Summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling 158,466 bottles of Pantoprazole Sodium Delayed-Release Tablets, USP (40 mg), a prescription medication used to treat acid reflux and stomach ulcers. This recall was initiated because some tablets may have dark discoloration or brown spots on their edges. Consumers who take this medication should check their bottles immediately to see if their specific lot is affected by this quality issue.

Risk

The presence of dark discoloration or brown spots on the tablets indicates a quality defect that may affect the stability or purity of the medication. While no specific injuries were reported, taking discolored medication could potentially lead to reduced effectiveness or unexpected side effects.

What You Should Do

Check your prescription bottle for the product name 'Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg' in 90-count bottles with NDC 59746-284-90.
Verify if your bottle matches one of the following lot numbers and expiration dates: PA26038A (Exp 04/19); PA26039A, PA26040A, or PA26050A (Exp 05/19); PA26052A (Exp 06/19); PA26073A (Exp 07/19); PA217071A, PA217072A, PA217073B, or PA217074B (Exp 06/20); PA217101A (Exp 08/20); or PA218023A (Exp 01/21).
If your medication is part of the recall, contact your healthcare provider or pharmacist for guidance on obtaining a replacement and do not stop taking your medication until you have a replacement supply.
Return any unused product from the affected lots to your pharmacy for a refund and contact Jubilant Cadista Pharmaceuticals, Inc. at their Salisbury, Maryland location 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

Pharmacy refund and healthcare consultation

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-0011-2019

Lot Numbers:

PA26038A (Exp 04/19)

PA26039A (Exp 05/19)

PA26040A (Exp 05/19)

PA26050A (Exp 05/19)

PA26052A (Exp 06/19)

PA26073A (Exp 07/19)

PA217071A (Exp 06/20)

PA217072A (Exp 06/20)

PA217073B (Exp 06/20)

PA217101A (Exp 08/20)

PA218023A (Exp 01/21)

Date Ranges: 04/19, 05/19, 06/19, 07/19, 06/20, 08/20, 01/21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81162

Status: Resolved

Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 158,466 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

Check your prescription bottle for the product name 'Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg' in 90-count bottles with NDC 59746-284-90.

Verify if your bottle matches one of the following lot numbers and expiration dates: PA26038A (Exp 04/19); PA26039A, PA26040A, or PA26050A (Exp 05/19); PA26052A (Exp 06/19); PA26073A (Exp 07/19); PA217071A, PA217072A, PA217073B, or PA217074B (Exp 06/20); PA217101A (Exp 08/20); or PA218023A (Exp 01/21).

If your medication is part of the recall, contact your healthcare provider or pharmacist for guidance on obtaining a replacement and do not stop taking your medication until you have a replacement supply.

Return any unused product from the affected lots to your pharmacy for a refund and contact Jubilant Cadista Pharmaceuticals, Inc. at their Salisbury, Maryland location 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.

Affected Products

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

Model:

NDC 59746-284-90

Recall #: D-0011-2019

Lot Numbers:

PA26038A (Exp 04/19)

PA26039A (Exp 05/19)

PA26040A (Exp 05/19)

PA26050A (Exp 05/19)

PA26052A (Exp 06/19)

PA26073A (Exp 07/19)

PA217071A (Exp 06/20)

PA217072A (Exp 06/20)

PA217073B (Exp 06/20)

PA217101A (Exp 08/20)

PA218023A (Exp 01/21)

Date Ranges: 04/19, 05/19, 06/19, 07/19, 06/20, 08/20, 01/21