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Class III · Lower riskRecall completed

Amoxicillin And Clavulanate Potassium

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

Does this affect you?
Check your lot numberLot FP8735, 8/2017
Where it was soldNY, OH
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

Subpotent Drug; Clavulanic Acid

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 bySandoz Inc
Brand nameAMOXICILLIN AND CLAVULANATE POTASSIUM
Generic nameAMOXICILLIN AND CLAVULANATE POTASSIUM
Active ingredient(s)AMOXICILLIN, CLAVULANATE POTASSIUM
Distributed by / forSandoz Inc
NDC0781-1831-20
Show the full FDA record
Full product labelAmoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
Recalling firmSandoz Inc
DistributionNY, OH
Quantity4,464 bottles
Recall initiated2017-04-26
Report date2017-06-07
Recall completed2019-08-19
Recall numberD-0868-2017
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

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.