Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg Recalled by Macleods Pharma Usa Inc Due to CGMP Deviations- AZIDO Impurity levels observed to be...

Date: June 10, 2022
Company: Macleods Pharma Usa Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Macleods Pharma Usa Inc directly.

Affected Products

Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Quantity: 84/1000 count bottles

Why Was This Recalled?

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Macleods Pharma Usa Inc

Macleods Pharma Usa Inc has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report