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Class III · Lower riskRecall completed

Candesartan Cilexetil And Hydrochlorothiazide

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

Does this affect you?
Check your lot numberLot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
Where it was soldNationwide within the United States
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

Out-of-specification organic impurity results 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 byMylan Pharmaceuticals Inc.
Brand nameCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Generic nameCANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Active ingredient(s)CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
Distributed by / forMylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A
NDC0378-3002-77
Show the full FDA record
Full product labelCandesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Recalling firmMylan Pharmaceuticals Inc.
DistributionNationwide within the United States
Quantity10,695 bottles
Recall initiated2020-10-02
Report date2020-10-28
Recall completed2022-01-24
Recall numberD-0049-2021
ClassificationClass III
FDA statusTerminated
Origin on fileMorgantown WV United States

Related

Hydrochlorothiazide recallsRecent drug recallsCheck another medication

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.