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Class II · ModerateRecall completed

Lisinopril tablets

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

Does this affect you?
Check your lot numberLot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18
Where it was soldU.S. Nationwide 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

Failed tablet/capsule specification: missing break line on the 5mg tablet.

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 / forAccord Healthcare, Inc., Durham, NC 27703
NDC16729-376-17
Show the full FDA record
Full product labelLisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Recalling firmAccord Healthcare, Inc.
DistributionU.S. Nationwide and Puerto Rico
Quantity12896 bottles
Recall initiated2016-12-20
Report date2017-02-22
Recall completed2017-08-02
Recall numberD-0478-2017
ClassificationClass II
FDA statusTerminated
Origin on fileDurham NC 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.