FDA Drug recall D-0026-2019
Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Taked…
- FDA Drug
- Class II
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class II recall of Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Taked… by Takeda Development Center Americas, citing defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0026-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-10 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Takeda Development Center Americas |
| Distribution | AR, LA, MS, NC, NJ, OH, PA, PR, SC |
Product
Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30
Reason
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Identifiers
| code_info | Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020 |
|---|
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-0026-2019%22
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