The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0102-2019·Announced 2018-10-31

Teva Recalls Pioglitazone and Metformin Tablets Due to Defective Delivery System

Teva Pharmaceuticals USA is recalling specific lots of Pioglitazone and Metformin tablets because some may lack laser drilling, potentially affecting drug release.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect poses a risk of harm by potentially affecting drug release, but no injuries or illnesses have been reported.

Plain-English summary

Teva Pharmaceuticals USA is recalling specific lots of Pioglitazone and Metformin extended-release tablets, marketed under the brand name Actoplus Met XR. The recall involves 15 mg/1000 mg tablets packaged in fiber drums.

The recall is due to a defective delivery system where some tablets may be missing laser drilling. This defect might affect the release of the drug. The affected bulk product was distributed throughout the United States to Takeda in Deerfield, IL, and may have been further distributed.

Consumers should check their medication for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda…
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Bulk Lot no 1250668
  • 15 mg/1000 mg Bulk product No # 1274150
  • no NDC Codes
  • bulk exp. date 05/2020 & 10/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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