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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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
- Manufacturer
- Teva Pharmaceutical Industries
- Category
- Drug — Prescription Drug
- Hazard
- 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.
Related recalls
Same brand · IRBESARTAN AND HYDROCHLOROTHIAZIDE
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- LowPrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Error
FDA (Drugs) · 2016-06-29
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- LowPrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Error
FDA (Drugs) · 2016-06-29
- SevereTeva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-01
- SevereTeva Recalls Moexipril Hydrochloride Tablets Due to Impurity Test Failure
FDA (Drugs) · 2018-01-17
- ModerateTeva Recalls Terazosin Hydrochloride Capsules Due to Labeling Error
FDA (Drugs) · 2013-08-14
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SevereTeva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
FDA (Drugs) · 2018-12-19