CLASS III Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report

Candesartan Cilexetil Tablets, 8 mg recalled by Apotex

Apotex is recalling Candesartan Cilexetil Tablets, 8 mg, 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

Lot, batch or date codesLot # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15

Quantity recalled18,493

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-0242-2015
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, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

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 # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15

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 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.

Other products in this recall event

3 other products · FDA event 69546

This product is part of a recall event; the main page for the event is Candesartan Cilexetil Tablets, 4 mg recalled by Apotex.

Reported	Class	Recall	Company	Reason	Where
12 Nov 2014	CLASS III	Candesartan Cilexetil Tablets, 4 mg recalled by Apotex	Apotex	Potency & Assay	Nationwide
12 Nov 2014	CLASS III	Candesartan Cilexetil Tablets, 32 mg, a) bottle recalled by Apotex	Apotex	Potency & Assay	Nationwide
12 Nov 2014	CLASS III	Candesartan Cilexetil Tablets, 16 mg, a) bottle recalled by Apotex	Apotex	Potency & Assay	Nationwide

More recalls from Apotex

All 76

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Other Candesartan Cilexetil recalls

All 11

Reported	Class	Recall	Company	Reason	Where
22 Sep 2021Drug	CLASS III	Candesartan Cilexetil Tablets, USP 16 mg recalled by ViatrisCandesartan Cilexetil	Viatris	Potency & Assay	Nationwide
28 Oct 2020Drug	CLASS III	Candesartan Cilexetil and Hydrochlorothiazide Tablets recalledCandesartan Cilexetil And Hydrochlorothiazide	Mylan Pharmaceuticals	Potency & Assay	Nationwide
17 Feb 2016Drug	CLASS III	Candesartan Cilexetil Tablets, 16 mg, a) recalled by Sandoz	Sandoz	Potency & Assay	Nationwide
17 Feb 2016Drug	CLASS III	Candesartan Cilexetil Tablets, 16 mg (5 x, Rx recalled	Amerisource Health Services	Potency & Assay	Nationwide
10 Dec 2014Drug	CLASS III	candesartan cilexetil, tablets, 16 mg recalled by Sandoz	Sandoz	Potency & Assay	Nationwide