CLASS III Drug recall · Reported 24 Sep 2014 · FDA Enforcement Report

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg recalled

Apotex is recalling Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, distributed nationwide in the US. The recall was initiated on 21 Aug 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # KK6086, exp 03/2015, UPC 360505375998.

Quantity recalled1,494 bottles

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-1570-2014
FDA event ID: 69170
Recalling firm: Apotex, Weston, FL
Classification: Class III
Status: Terminated
Recall initiated: 21 Aug 2014
FDA classified: 15 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

21 Aug 2014	Recall initiated by company
15 Sep 2014	Classified by FDA	+25 days
24 Sep 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

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 and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

Which lots are affected?

Lot # KK6086, exp 03/2015, UPC 360505375998.

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.

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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