Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported October 31, 2012
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Bristol-myers Squibb Company recalled Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-… - a moderate-severity action.
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-… was recalled by Bristol-myers Squibb Company in October 31, 2012. Reason: Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as …. Check the official notice for the remedy. Verify recall #D-018-2013 with the FDA Drug before acting.
The recall
Bristol-myers Squibb Company issued this moderate-severity FDA Drug recall-Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as ….
- Moderate
- severity level
- Class II
- classification
- October 31, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-018-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-018-2013) was formally reported on October 31, 2012, with the manufacturer initiating the action on June 5, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Bristol-myers Squibb Company is listed as the recalling firm, operating out of New Brunswick, NJ. Federal records list the affected scope as 117,049 Sample Cartons.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
117,049 Sample Cartons
Related Recalls
6
5 from same agency
Product description
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-018-2013 |
| Date reported | October 31, 2012 |
| Date initiated | June 5, 2012 |
| Recalling firm | Bristol-myers Squibb Company |
| Firm location | New Brunswick, NJ |
| Affected scope | 117,049 Sample Cartons |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-018-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 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.. Recalled by Bristol-myers Squibb Company. Units affected: 117,049 Sample Cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2012. Severity: Moderate. Recall number: D-018-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-018-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 31, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.