Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Is Candesartan recalled?
Not under an active recall.
Candesartan was recalled 12 times in the past — all now closed. Most recent: Sep 13, 2021.
Most common reason: Impurity / degradation (11 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Candesartan. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Candesartan recalls on record
none so far in 2026; 12 on record, newest first
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets
Out-of-specification organic impurity results obtained during routine stability testing.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
candesartan cilexetil
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Class II · Moderate risk
Candesartan Cilexetil
Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: W003649, EXP: 6/25/2014.
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