# FDA recall D-0026-2019

> **Takeda Development Center Americas, Inc.** · Class II · drug recall initiated 2018-09-10.

## 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.

## Distribution

AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico

## Key facts

- **Recall number:** D-0026-2019
- **Recalling firm:** Takeda Development Center Americas, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-10
- **Report date:** 2018-10-17
- **Termination date:** 2020-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0026-2019

## Citation

> AI Analytics. FDA recall D-0026-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0026-2019. Source: US FDA. Licensed CC0.

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