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Class III · Lower riskRecall completed

Irbesartan And Hydrochlorothiazide

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 24I030, Exp 5/2017
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

Labeling: Incorrect or Missing Lot AND/OR Exp Date.

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 byTeva Pharmaceuticals USA, Inc.
Brand nameIRBESARTAN AND HYDROCHLOROTHIAZIDE
Generic nameIRBESARTAN AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, IRBESARTAN
Distributed by / forTEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960
NDC0093-8238-98
Show the full FDA record
Full product labelIrbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98
Recalling firmTeva Pharmaceutical Industries
DistributionNationwide
Quantity3536 bottles
Recall initiated2015-10-20
Report date2015-12-23
Recall completed2016-11-01
Recall numberD-0521-2016
ClassificationClass III
FDA statusTerminated
Origin on fileJerusalem N/A Israel

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.