Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sotalol HCL Tablets Recalled by Mylan Pharmaceuticals Inc. Due to Presence of particulate matter. presence of metal particles.
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 Pharmaceuticals Inc. directly.
Affected Products
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Quantity: 300 100-count bottles
Why Was This Recalled?
Presence of particulate matter. presence of metal particles.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report