Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fexofenadine HCl Tablets Recalled by Mylan Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications: out of specification results for...
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
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.
Quantity: 13,856 Bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
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