Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amlodipine and Valsartan Tablets Recalled by Mylan Laboratories Limited, (Nashik FDF) Due to GCMP Deviations: FDA analysis confirmed presence of trace...
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 Mylan Laboratories Limited, (Nashik FDF) directly.
Affected Products
Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.
Quantity: 84,066 HDPE bottles
Why Was This Recalled?
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Where Was This Sold?
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
About Mylan Laboratories Limited, (Nashik FDF)
Mylan Laboratories Limited, (Nashik FDF) has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report