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Lower risk Drug recall · FDA · Published September 10, 2018

Takeda Actoplus met XR tablets recall: Missing laser holes risk improper release

Takeda recalls 15 mg/1000 mg Actoplus met XR tablets with missing laser holes on metformin core. These tablets may not release medication properly. Check NDC 64764-510-30, lots A26004 (exp Apr 2020) and A26443/A26444 (exp Sep 2020).

🇺🇸 FDA recall #D-0026-2019DrugTakeda ›
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Recalling firmTakeda Development Center Americas, Inc.1 Takeda Pkwy, 4034BB1 · Deerfield, IL 60015-5713
✎ GovInfoNow plain-language explainer

What happened, in plain English

Takeda is recalling Actoplus met XR tablets that may have missing laser holes on the metformin core. This defect could cause the tablets to not release medication properly, potentially leading to incorrect dosing. Read more at govinfonow.com/recall/39579-takeda-actoplus-met-xr-tablets-recall-missing-laser-holes-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39579-takeda-actoplus-met-xr-tablets-recall-missing-laser-holes-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0026-2019

Cite this page

“Takeda Actoplus met XR tablets recall: Missing laser holes risk improper release.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39579-takeda-actoplus-met-xr-tablets-recall-missing-laser-holes-risk. Based on FDA recall #D-0026-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0026-2019%22&limit=1).

Why it’s dangerous

The laser-drilled holes on the metformin core are critical for the tablet's proper release mechanism. If these holes are missing or incomplete, the medication may not be released correctly, potentially causing incorrect dosing.

Who’s affected

Prescription drug users who have the specific 30-tablet bottle of Actoplus met XR (15 mg/1000 mg) with NDC 64764-510-30 and lots A26004 (expiring April 2020) or A26443/A26444 (expiring September 2020).

How to tell if you have this one

Check the product label for the NDC code 64764-510-30. Look for specific lot numbers: A26004 (expires April 2020) or A26443 and A26444 (expires September 2020).

  • Brand
    Takeda
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the NDC code 64764-510-30 and lot numbers A26004 (expiring April 2020) or A26443/A26444 (expiring September 2020).

Where it went and when

Where it was distributed

Distributed in 8 states and Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFLPuerto Rico: yesPR

FDA distribution: “AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, Louisiana, Mississippi, New Jersey, North Carolina, Ohio, Pennsylvania, Puerto Rico, South Carolina.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Sep 10, 201812. FDA classified it Class II: Oct 15, 201823. Published in FDA’s Enforcement Report: Oct 17, 201834. FDA terminated the recall: Apr 13, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0026-2019 (September 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0026-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA