RecallRadar

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…

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

AgencyFDA Drug
Recall numberD-0026-2019
ClassificationClass II
Statusterminated
Initiated2018-09-10
Published2018-10-17
Last updated2026-09-13 11:52 UTC
CompanyTakeda Development Center Americas
DistributionAR, 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_infoLot, 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

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.