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Class II · ModerateRecall completed

Amoxicillin for Oral Suspension USP

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

Does this affect you?
Check your lot numberLot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19
Where it was soldUnited States and Puerto Rico
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

Subpotency: due to a low, 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

Distributed by / forTEVA PHARMACEUTICALS USA, Sellersville, PA 18960
NDC0093-4150-73
Show the full FDA record
Full product labelAmoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Recalling firmTeva Pharmaceuticals USA
DistributionUnited States and Puerto Rico
Quantity133,601 bottles
Recall initiated2016-12-21
Report date2017-02-01
Recall completed2018-02-06
Recall numberD-0440-2017
ClassificationClass II
FDA statusTerminated
Origin on fileNorth Wales 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.