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Class II · ModerateRecall completed

Pantoprazole Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: MHC1317A, Exp 07/2023
Where it was soldNationwide in the USA.
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

Discoloration

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 Limited Mohali, INDIA foreign manufacturer
Brand namePANTOPRAZOLE SODIUM
Generic namePANTOPRAZOLE SODIUM
Active ingredient(s)PANTOPRAZOLE SODIUM
Distributed by / forSun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
NDC62756-071-60
Show the full FDA record
Full product labelPantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA.
Quantity14, 064 (30 sachets in a carton)
Recall initiated2022-07-25
Report date2022-11-30
Recall completed2023-09-13
Recall numberD-0068-2023
ClassificationClass II
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.