Actoplus met XR — Class II drug recall D-0026-2019
Terminated recall by Takeda Development Center Americas, Inc., reported 2018-10-17, distributed in AR, LA, MS, NC, NJ, OH, PA, PR…. Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metform
| Recall number | D-0026-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Takeda Development Center Americas, Inc., Deerfield, IL, United States |
| Recall initiated | 2018-09-10 |
| Classified | 2018-10-15 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2020-04-13 |
| Distributed | AR, LA, MS, NC, NJ, OH, PA, PR, SC |
| Quantity | 7,248 bottles |
| NDC | 64764-0510-30 |
| Lot numbers | A26004, A26443, A26444 |
| Expiration dates | 2020-04-20, 2020-09-20 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0026-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.