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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 numberBatch 35447184A
Where it was soldNationwide 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

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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 PHARMACEUTICALS USA, INC., North Wales, PA 19454
NDC0093-4161-73
Show the full FDA record
Full product labelAMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
Recalling firmCARDINAL HEALTHCARE
DistributionNationwide USA
Quantity3 units
Recall initiated2022-01-26
Report date2024-01-03
Recall completed2024-09-29
Recall numberD-0165-2024
ClassificationClass II
FDA statusTerminated
Origin on fileDublin OH 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.