Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Isotretinoin Capsules Recalled by MYLAN PHARMACEUTICALS INC Due to Failed Dissolution Specifications
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
Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Quantity: 34850 blister packs
Why Was This Recalled?
Failed Dissolution Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MYLAN PHARMACEUTICALS INC
MYLAN PHARMACEUTICALS INC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report