CLASS II Drug recall · Reported 31 Oct 2012 · FDA Enforcement Report

Kombiglyze XR (saxagliptin and metformin HCl recalled

Bristol-myers Squibb is recalling Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician, distributed nationwide in the US. The recall was initiated on 5 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13

Quantity recalledN/A

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-019-2013
FDA event ID: 62898
Recalling firm: Bristol-myers Squibb, New Brunswick, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Jun 2012
FDA classified: 24 Oct 2012
Reported: 31 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Drug class: Diabetes Medication

Timeline

5 Jun 2012	Recall initiated by company
24 Oct 2012	Classified by FDA	+141 days
31 Oct 2012	Published in enforcement report	+7 days

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

Reason for recall

Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.

Product as listed by the FDA

Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

1 other product · FDA event 62898

Reported	Class	Recall	Company	Reason	Where
31 Oct 2012	CLASS II	Kombiglyze XR (saxagliptin and metformin HCl recalled	Bristol-myers Squibb	Labeling Errors	Nationwide

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Other Kombiglyze (saxagliptin recalls

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Reported	Class	Recall	Company	Reason	Where
31 Oct 2012Drug	CLASS II	Kombiglyze XR (saxagliptin and metformin HCl recalled	Bristol-myers Squibb	Labeling Errors	Nationwide