Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets Recalled by Macleods Pharma Usa Inc Due to CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected...
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 andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10
Quantity: 145162 bottles (13,064,580 tablets)
Why Was This Recalled?
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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