Is Candesartan recalled?

12 FDA recalls mention Candesartan. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Candesartan.

Class III · Low risk Terminated Sep 13, 2021

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…

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

Viatris NDC 0378-3231-93 D-0798-2021

Class III · Low risk Terminated Mar 22, 2021

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ…

Reason Failed Impurities/Degradation Specifications

Macleods Pharma Usa Inc NDC 33342-114-10 D-0329-2021

Class III · Low risk Terminated Oct 2, 2020

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and…

Reason Out-of-specification organic impurity results obtained during routine stability testing.

Mylan Pharmaceuticals Inc. NDC 0378-3002-77 D-0049-2021

Class III · Low risk Terminated Jan 26, 2016

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus…

Reason Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

Amerisource Health Services NDC 68084-877-25 D-0660-2016

Class III · Low risk Terminated Dec 31, 2015

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only…

Reason Failed Impurities/Degradation Specifications; 9 month stability timepoint

Sandoz Inc NDC 00781-5938-31 D-0659-2016

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3621-3 D-0244-2015

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3620-3 D-0243-2015

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3619-3 D-0242-2015

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3618-3 D-0241-2015

Class III · Low risk Terminated Oct 2, 2014

candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan…

Reason Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone…

Sandoz, Inc NDC 0781-5938-92 D-0288-2015

Class III · Low risk Terminated Aug 21, 2014

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research…

Reason Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

Apotex Corp. NDC 60505-3759-9 D-1570-2014

Class II · Moderate risk Terminated Jul 2, 2013

CANDESARTAN CILEXETIL, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00186001631.

Reason Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg…

Aidapak Services, LLC D-882-2014

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