US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 25, 2019 (8 years ago)

Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

What was recalled

Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07

Recalling firm
Macleods Pharma Usa Inc
NDC code
33342-128-07
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1003-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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