CLASS III Drug recall · Reported 17 Feb 2016 · FDA Enforcement Report

Candesartan Cilexetil Tablets, 16 mg, a) recalled by Sandoz

Sandoz is recalling Candesartan Cilexetil Tablets, 16 mg, a) (, distributed nationwide in the US. The recall was initiated on 31 Dec 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017

Quantity recalled277,267 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-0659-2016
FDA event ID: 73035
Recalling firm: Sandoz, Princeton, NJ
Classification: Class III
Status: Terminated
Recall initiated: 31 Dec 2015
FDA classified: 11 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

31 Dec 2015	Recall initiated by company
11 Feb 2016	Classified by FDA	+42 days
17 Feb 2016	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; 9 month stability timepoint

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, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

Where it was distributed

Nationwide

Questions about this recall

Is Candesartan Cilexetil Tablets, 16 mg, a) ( recalled?

Yes. Sandoz recalled Candesartan Cilexetil Tablets, 16 mg, a) ( on 31 Dec 2015. The recall is Class III and its status is Terminated. Recall number D-0659-2016.

Why was it recalled?

Failed Impurities/Degradation Specifications; 9 month stability timepoint

Which lots are affected?

a) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017

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
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 (5 x, Rx recalled	Amerisource Health Services	Potency & Assay	Nationwide
12 Nov 2014Drug	CLASS III	Candesartan Cilexetil Tablets, 8 mg recalled by Apotex	Apotex	Potency & Assay	Nationwide
12 Nov 2014Drug	CLASS III	Candesartan Cilexetil Tablets, 16 mg, a) bottle recalled by Apotex	Apotex	Potency & Assay	Nationwide