SUN PHARMACEUTICAL INDUSTRIES INC recalls Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical recalls Pantop: 40mg IV injection due to failed impurity specifications. Affected units have NDC 62756-129-40 or specific codes. No remedy stated in recall notice.
Recall notice
Failed Impurity/Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling Pantoprazole Sodium 40mg for IV injection because it failed impurity and degradation tests. This could pose a risk if the medication is used improperly, though the recall does not specify a remedy. Read more at govinfonow.com/recall/36530-sun-pharmaceutical-pantoprazole-sodium-40mg-injection-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36530-sun-pharmaceutical-pantoprazole-sodium-40mg-injection-recall-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0251-2021
Cite this page
“Sun Pharmaceutical Pantoprazole Sodium 40mg Injection Recall: Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36530-sun-pharmaceutical-pantoprazole-sodium-40mg-injection-recall-impurity-risk. Based on FDA recall #D-0251-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0251-2021%22&limit=1).
Why it’s dangerous
The medication may contain harmful impurities or degrade in a way that could affect safety during IV use. This could lead to adverse reactions if the product is not properly stored or handled.
Who’s affected
Healthcare professionals using this medication for IV infusion. Patients receiving treatment with this product are at risk if the medication is improperly handled.
How to tell if you have this one
Check for NDC code 62756-129-40 or codes JKU3595A, JKU3596A, JKU3597A, JKU3629A on the vial. The product was distributed by Sun Pharmaceutical Industries, Inc. in the US and manufactured in India.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 62756-129-40 or specific codes JKU3595A, JKU3596A, JKU3597A, JKU3629A on the vial label.
Questions people ask
Is there a remedy for this recall?
The recall notice does not state any remedy.
What is the specific problem with this medication?
The medication failed impurity and degradation specifications, which could pose a risk during IV infusion.
How can I tell if I have the recalled product?
Check for NDC code 62756-129-40 or codes JKU3595A, JKU3596A, JKU3597A, JKU3629A on the vial label.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0251-2021 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0251-2021 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0251-2021 (February 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0251-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.