Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications
Candesartan Cilexetil Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Affected NDC
0378-3231-93
Compare with the code on your package — it is the most precise check available.
Drug: Candesartan Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| candesartan cilexetil NDC 00378-3231 |
16 mg/1 | Tablet Oral |
Mylan Pharmaceuticals Inc. | Rx |
- Recalling firm
- Viatris
- NDC code
- 0378-3231-93
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0798-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Candesartan recalls
See all
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.
Other recalls by Viatris
All 2021 recalls
Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
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