Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Recalled by AVKARE Inc. Due to CGMP Deviations: FDA lab confirmed presence of an...
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 AVKARE Inc. directly.
Affected Products
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Quantity: 1438 cartons (71,900 tablets)
Why Was This Recalled?
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AVKARE Inc.
AVKARE Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report