Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets Recalled by Bristol-myers Squibb Company Due to Labeling; Correct labeled product miscart/mispack: Some Physician sample...

Date: June 5, 2012
Company: Bristol-myers Squibb Company
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bristol-myers Squibb Company directly.

Affected Products

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.

Quantity: N/A

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bristol-myers Squibb Company

Bristol-myers Squibb Company has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report