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Class II · ModerateRecall completed

Amoxicillin

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

Does this affect you?
Check your lot numberLot # 35434158A, Exp 6/17
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

Superpotent drug: Out of specification test result for assay during stability testing.

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 byTeva Pharmaceuticals USA, Inc.
Brand nameAMOXICILLIN
Generic nameAMOXICILLIN
Active ingredient(s)AMOXICILLIN
Distributed by / forTeva North America
NDC0093-4161-76
Show the full FDA record
Full product labelAmoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Recalling firmTeva North America
DistributionNationwide
Quantity53,328 bottles
Recall initiated2016-06-24
Report date2016-08-31
Recall completed2017-02-07
Recall numberD-1470-2016
ClassificationClass II
FDA statusTerminated
Origin on fileHorsham PA United States

Related

Amoxicillin 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.