The Recall Desk
LowFDA (Drugs)·D-0521-2016·Announced 2015-12-23

Teva Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Errors

Teva Pharmaceutical Industries is recalling 3,536 bottles of Irbesartan and Hydrochlorothiazide tablets because some bottles have incorrect or missing lot and expiration dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error (incorrect or missing lot/exp date).

Plain-English summary

Teva Pharmaceutical Industries is recalling 3,536 bottles of Irbesartan and Hydrochlorothiazide tablets USP 150 mg/12.5 mg, 90-count. The recall was initiated because some bottles have incorrect or missing lot and expiration dates.

The affected product is Lot # 24I030, with an expiration date of 5/2017. The product was distributed nationwide. The tablets are prescription-only and were manufactured in Israel by Teva Pharmaceutical Industries Ltd. for Teva Pharmaceutical Industries USA.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA classifies this as a Class III recall, which is the lowest risk classification, indicating that the labeling error is unlikely to cause adverse health consequences.

The recalled product

Product
IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
Brand
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Affected units
3,536

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 (2)

  • Lot #: 24I030
  • Exp 5/2017

UPCs (1)

  • 0300938238569

Distribution

Distributed nationwide across the United States.