Class III · Lower riskRecall completed

Candesartan Cilexetil

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

Does this affect you?

Check your lot numberLot # 3107334, exp. date October 2021

Where it was soldProduct was distributed nationwide.

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 Impurities/Degradation Specifications; out of specification for Related Compound

What to do

Check the lot number and expiry on your medicine against the recall above.
Talk to your pharmacist or doctor before changing anything — don't stop on your own.
Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMylan Pharmaceuticals Inc.

Brand name	CANDESARTAN CILEXETIL
Generic name	CANDESARTAN CILEXETIL
Active ingredient(s)	CANDESARTAN CILEXETIL
Distributed by / for	Mylan Pharmaceuticals Inc., Morgantown, WV 26505
NDC	0378-3231-93

Show the full FDA record

Full product label	Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Recalling firm	Viatris
Distribution	Product was distributed nationwide.
Quantity	21,094
Recall initiated	2021-09-13
Report date	2021-09-22
Recall completed	2022-04-28
Recall number	D-0798-2021
Classification	Class III
FDA status	Terminated
Origin on file	Morgantown WV United States

Recent drug recalls Check 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.