CLASS III Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report
Candesartan Cilexetil Tablets, 32 mg, a) bottle recalled by Apotex
Apotex is recalling Candesartan Cilexetil Tablets, 32 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 16 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-0244-2015
- FDA event ID
- 69546
- Recalling firm
- Apotex, Toronto, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Oct 2014
- FDA classified
- 6 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 16 Oct 2014 | Recall initiated by company | |
| 6 Nov 2014 | Classified by FDA | +21 days |
| 12 Nov 2014 | Published in enforcement report | +6 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: Out of specification (OOS) results were observed for CAD-II, CAD-V 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, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Where it was distributed
Nationwide.
Questions about this recall
Is Candesartan Cilexetil Tablets, 32 mg, a) bottle ( recalled?
Yes. Apotex recalled Candesartan Cilexetil Tablets, 32 mg, a) bottle ( on 16 Oct 2014. The recall is Class III and its status is Terminated. Recall number D-0244-2015.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Which lots are affected?
Lot #: a) KR3955; Exp. 10/15, KV0430, Exp. 11/15 Lot #: b) KT6063; Exp. 10/15
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Candesartan cilexetil recalls
All 8| 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 |