Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fludrocortisone Acetate Tablets Recalled by Teva Pharmaceuticals USA, Inc Due to Failed Impurities/Degradation Specifications: Product is being recalled due...
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, Inc directly.
Affected Products
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
Quantity: 116,144 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA, Inc
Teva Pharmaceuticals USA, Inc has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report