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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 numberCK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15
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

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

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 bySandoz Inc
Brand nameAMOXICILLIN
Generic nameAMOXICILLIN
Active ingredient(s)AMOXICILLIN
Distributed by / forSandoz Incorporated
NDC0781-2613-05
Show the full FDA record
Full product labelAmoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.
Recalling firmSandoz Incorporated
DistributionNationwide
Quantity8286 x 30 ct, 37108 x 500 ct. bottles
Recall initiated2013-04-18
Report date2013-05-01
Recall completed2014-02-26
Recall numberD-268-2013
ClassificationClass II
FDA statusTerminated
Origin on fileBroomfield CO 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.