Telmisartan Hydrochlorothiazide Tablets (Macleods) – Blend Uniformity Issue (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
Brand
Macleods Pharma Usa Inc
Lot Codes / Batch Numbers
Lot #: BTN703A, BTN704A Exp Feb-19, BTN705A, BTN706A, Exp May-19, BTN707A, Exp Jun-19, BTN810A, Exp Jun-20, BTN811A, BTN812A Exp Aug-20, BTN813A, BTN814A, Exp Sep-20, BTN802A, BTN802B, BTN803A, BTN804A, Exp Dec-19, BTN805A, BTN806A, BTN807A, BTN807B, Exp Feb-20, BTN808A, Exp Apr-20, BTN809A, BTN810A, Exp Jun-20, BTN811A, BTN812A, Exp Aug-20, BTN813A, BTN814A, Exp Sep-20.
Products Sold
Lot #: BTN703A, BTN704A Exp Feb-19; BTN705A, BTN706A, Exp May-19; BTN707A, Exp Jun-19; BTN810A, Exp Jun-20; BTN811A, BTN812A Exp Aug-20; BTN813A, BTN814A, Exp Sep-20; BTN802A, BTN802B, BTN803A, BTN804A, Exp Dec-19; BTN805A, BTN806A, BTN807A, BTN807B, Exp Feb-20; BTN808A, Exp Apr-20; BTN809A, BTN810A, Exp Jun-20; BTN811A, BTN812A, Exp Aug-20; BTN813A, BTN814A, Exp Sep-20.
Macleods Pharma Usa Inc is recalling Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for due to Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026