FDAClass IIISeptember 22, 2021

Candesartan Cilexetil Tablets recall: Impurity Out of Spec

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

Why was Candesartan Cilexetil Tablets recalled?

Failed Impurities/Degradation Specifications; out of specification for Related Compound

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 3107334, exp. date October 2021

Product
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Recalling firm
Viatris
Quantity
21,094
Distribution
Product was distributed nationwide.
Recall date
September 22, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls