Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amlodipine Recalled by Teva Pharmaceuticals USA Due to CGMP Deviations: FDA laboratory testing confirmed presence of...
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 Teva Pharmaceuticals USA directly.
Affected Products
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Quantity: 37,957 bottles
Why Was This Recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA
Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report