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Class II · ModerateRecall completed

Amoxicillin for Oral Suspension

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

Does this affect you?
Check your lot numberLot #s: a) T200112; b) T200103, T200113; c) T200104, T200114
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

Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.

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 / forDr Reddys Laboratories Tennessee LLC
NDC43598-222-80
Show the full FDA record
Full product labelAmoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807
Recalling firmDr Reddys Laboratories Tennessee LLC
DistributionNationwide
Quantity4236 Bottles
Recall initiated2013-02-15
Report date2013-04-10
Recall completed2013-10-01
Recall numberD-239-2013
ClassificationClass II
FDA statusTerminated
Origin on fileBristol TN 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.