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Class III · Lower riskRecall completed

Amoxicillin

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

Does this affect you?
Check your lot numberLot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
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

Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

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, Sellersville, PA 18960
NDC0093-4160-78
Show the full FDA record
Full product labelAmoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Recalling firmTeva Pharmaceuticals USA, Inc.
DistributionNationwide
Quantity109,080 Bottles
Recall initiated2013-06-18
Report date2013-07-24
Recall completed2013-12-24
Recall numberD-803-2013
ClassificationClass III
FDA statusTerminated
Origin on fileSellersville 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.