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Class II · ModerateRecall completed

Metoprolol Succinate Extended Release Tablets

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

Does this affect you?
Check your lot numberLot # 1220211M, Exp 02/2019
Where it was soldU.S.A. Nationwide including 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 dissolution specifications: Out-of-Specification dissolution test result obtained during routine 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

Made byActavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Distributed by / forActavis Pharma, Inc., Parsippany, NJ 07054
NDC62037-831-01
Show the full FDA record
Full product labelMetoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
Recalling firmTeva Pharmaceuticals USA
DistributionU.S.A. Nationwide including Puerto Rico.
Quantity53,451 bottles
Recall initiated2018-10-19
Report date2018-10-31
Recall completed2019-04-03
Recall numberD-0129-2019
ClassificationClass II
FDA statusTerminated
Origin on fileNorth Wales PA 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.