CLASS II Drug recall · Reported 17 Oct 2018 · FDA Enforcement Report
Actoplus met XR (pioglitazone and metformin HCl recalled
Takeda Development Center Americas is recalling Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, distributed in 9 states. The recall was initiated on 10 Sep 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0026-2019
- FDA event ID
- 80964
- Recalling firm
- Takeda Development Center Americas, Deerfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2018
- FDA classified
- 15 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 10 Sep 2018 | Recall initiated by company | |
| 15 Oct 2018 | Classified by FDA | +35 days |
| 17 Oct 2018 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
ArkansasLouisianaMississippiNorth CarolinaNew JerseyOhioPennsylvaniaPuerto RicoSouth Carolina
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020
Where was it sold?
AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Takeda Development Center Americas
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Amitiza (lubiprostone) capsules 8 mcg recalledAmitiza | Takeda Development Center Americas | Potency & Assay | Nationwide |
Other Actoplus Met (pioglitazone recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Actoplus Met XR (Pioglitazone recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |