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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

SUN PHARMACEUTICAL INDUSTRIES INC: Pantoprazole Sodium for Injection Recalled for Impurity and Degradation

Agency Publication Date: February 9, 2021
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Summary

Sun Pharmaceutical Industries Inc. is recalling 20,475 vials of Pantoprazole Sodium for Injection 40mg/vial, a medication used to treat stomach and esophagus problems. This recall was initiated because the product failed to meet quality specifications for impurities and degradation. Consumers should be aware that affected vials were distributed nationwide and include specific lot numbers and an expiration date of February 2021. Because this medication is administered by healthcare professionals, patients should contact their doctor or pharmacist if they believe they received this product.

Risk

The drug failed to meet specific chemical purity and stability standards, which means the medication may contain higher levels of impurities or degraded components than are safely allowed. This can reduce the effectiveness of the treatment or potentially cause unexpected side effects during intravenous infusion.

What You Should Do

  1. Check your medical records or contact your healthcare provider to see if you were administered Pantoprazole Sodium for Injection 40mg/vial from lot numbers JKU3595A, JKU3596A, JKU3597A, or JKU3629A with an expiration date of 02/2021.
  2. If you have any unused vials from these specific lots (NDC 62756-129-40), stop using them immediately and do not administer them to patients.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any concerns.
  4. Return any unused product from the affected lots to the pharmacy or place of purchase for a refund.
  5. Contact Sun Pharmaceutical Industries Inc. at their Princeton, NJ headquarters for further instructions regarding the return of the recalled product.
  6. For additional information or to report a complaint, 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

Return product to 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 for Injection (40mg/vial)
Model:
NDC 62756-129-40
Recall #: D-0251-2021
Lot Numbers:
JKU3595A (Exp 02/2021)
JKU3596A (Exp 02/2021)
JKU3597A (Exp 02/2021)
JKU3629A (Exp 02/2021)
Date Ranges: Expiration 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87260
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: hospitals; clinics; pharmacies
Manufactured In: India, United States
Units Affected: 20,475 vials
Distributed To: Nationwide

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.