CLASS III Drug recall · Reported 10 Dec 2014 · FDA Enforcement Report
candesartan cilexetil, tablets, 16 mg recalled by Sandoz
Sandoz is recalling candesartan cilexetil, tablets, 16 mg, distributed nationwide in the US. The recall was initiated on 2 Oct 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0288-2015
- FDA event ID
- 69688
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Oct 2014
- FDA classified
- 2 Dec 2014
- Reported
- 10 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 2 Oct 2014 | Recall initiated by company | |
| 2 Dec 2014 | Classified by FDA | +61 days |
| 10 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 3007330, Exp 11/2014
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sandoz
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
Other Candesartan Cilexetil recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Candesartan Cilexetil Tablets, USP 16 mg recalled by ViatrisCandesartan Cilexetil | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil and Hydrochlorothiazide Tablets recalledCandesartan Cilexetil And Hydrochlorothiazide | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil Tablets, 16 mg, a) recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil Tablets, 16 mg (5 x, Rx recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil Tablets, 8 mg recalled by Apotex | Apotex | Potency & Assay | Nationwide |