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Class III · Lower riskRecall completed

Pantoprazole Sodium

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberJKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurity/Degradation Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India foreign manufacturer
Brand namePANTOPRAZOLE SODIUM
Generic namePANTOPRAZOLE SODIUM
Active ingredient(s)PANTOPRAZOLE SODIUM
Distributed by / forSun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
NDC62756-129-40
Show the full FDA record
Full product labelPantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide
Quantity20,475 vials
Recall initiated2021-02-05
Report date2021-02-17
Recall completed2021-11-03
Recall numberD-0251-2021
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Pantoprazole recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.