FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Xigduo

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberMP0077
Where it was soldFL, GA, SC
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791
Brand nameXIGDUO
Generic nameDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Active ingredient(s)DAPAGLIFLOZIN PROPANEDIOL, METFORMIN HYDROCHLORIDE
Distributed by / forAstraZeneca Pharmaceuticals LP Wilmington, DE 19850
NDC0310-6280-30
Show the full FDA record
Full product labelxigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791
Recalling firmCardinal Health Inc.
DistributionFL, GA, SC
Quantity664 bottles
Recall initiated2021-03-15
Report date2021-06-02
Recall completed2024-06-17
Recall numberD-0435-2021
ClassificationClass II
FDA statusTerminated
Origin on fileDublin OH United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.