Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Capecitabine Tablets Recalled by Mylan Pharmaceuticals Inc Due to Failed Dissolution Specifications: low out-of-specification (OOS) 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
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
Quantity: 1068 bottles
Why Was This Recalled?
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Pharmaceuticals Inc
Mylan Pharmaceuticals Inc has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report