Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Losartan Potassium and Hydrochlorothiazide Tablets Recalled by Macleods Pharma Usa Inc Due to CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen...
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 and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
Quantity: 9695 bottles
Why Was This Recalled?
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Where Was This Sold?
This product was distributed to 3 states: FL, NJ, NY
About Macleods Pharma Usa Inc
Macleods Pharma Usa Inc has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report