Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Candesartan Cilexetil Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
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, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
Affected NDC
33342-0114-10
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 NDC 33342-0114 |
CILEXETIL 4 mg/1 | Tablet Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharma Usa Inc
- NDC code
- 33342-114-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0329-2021 · 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 Macleods Pharma Usa Inc
All 2021 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
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