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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

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

Agency Publication Date: March 18, 2020
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Summary

Jubilant Cadista Pharmaceuticals is recalling approximately 89,376 bottles of Pantoprazole Sodium (generic Protonix) Delayed-Release Tablets, 40 mg, sold in 90-count bottles. The recall was initiated because dark brown discoloration was found on the edges of the tablets, which indicates a deviation from manufacturing quality standards. Consumers should check their prescription bottles for specific lot numbers and consult their healthcare provider or pharmacist before making changes to their medication routine.

Risk

The dark brown discoloration on the tablet edges suggests potential chemical degradation or manufacturing defects. Using compromised medication may result in reduced effectiveness or exposure to unknown impurities, posing a moderate risk to patient health.

What You Should Do

  1. Check your prescription bottle label to see if it is Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg in a 90-count bottle with NDC 59746-284-90.
  2. Verify the lot number and expiration date on the side of the bottle. Affected lots include PA218005A (Exp 12/2020), PA218P010 (Exp 04/2021), PA218P011 (Exp 04/2021), PA218108A (Exp 06/2021), and PA218110A (Exp 06/2021).
  3. Inspect the tablets for any dark brown discoloration specifically on the edges of the pills.
  4. Contact your healthcare provider or pharmacist immediately for guidance on a replacement medication. Do not stop taking your prescribed medication until you have a replacement or have spoken with a medical professional.
  5. Return any unused product from the affected lots to your pharmacy for a refund and contact Jubilant Cadista Pharmaceuticals for further instructions.
  6. 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

๐Ÿ’ฐFull Refund

Guidance and refund for discolored tablets.

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

Affected Products

Product: Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg (90-count bottle)
Model:
NDC 59746-284-90
Recall #: D-1058-2020
Lot Numbers:
PA218005A (Exp 12/2020)
PA218P010 (Exp 04/2021)
PA218P011 (Exp 04/2021)
PA218108A (Exp 06/2021)
PA218110A (Exp 06/2021)
Date Ranges: December 2020, April 2021, June 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85181
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 89,376 90-count bottles
Distributed To: Nationwide
Agency Last Updated: March 24, 2020

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 ยท 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.