MYLAN PHARMACEUTICALS INC

Drug Recalls (Class II)

Class II D-0399-2026 · 20260311 · Ongoing

Product

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.

Reason for Recall

Failed Dissolution Specifications

Distribution

Nationwide within the United States

Source: openFDA Enforcement API