FDA Drug recall D-0436-2021
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZe…
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZe… by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0436-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
Product
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 0310-6270-30 |
|---|---|
| ndc | 0310-6270-95 |
| ndc | 0310-6280-30 |
| ndc | 0310-6280-95 |
| ndc | 0310-6250-30 |
| ndc | 0310-6250-95 |
| ndc | 0310-6260-30 |
| ndc | 0310-6260-60 |
| ndc | 0310-6260-94 |
| ndc | 0310-6260-95 |
| ndc | 0310-6225-60 |
| ndc | 0310-6225-94 |
| code_info | ML0171 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0436-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.