Mylan recalls
4 federal recalls on file. We read every CPSC, FDA, USDA and NHTSA notice for Mylan and put it in plain English.
Recent recalls
Mylan prasugrel tablets recalled for failed dissolution specificationsMylan Pharmaceuticals is recalling Prasugrel 10mg tablets (Lot #3225272, expiring September 30, 2026) because they failed dissolution testing during 18-month stability studies. This means the tablets may not break down and release the medication as intended in the body. No injuries have been reported.
ModerateFDASep 9, 2026
- Mylan Mycophenolate Mofetil injection recalled for dissolution failure
Mylan Pharmaceuticals is recalling specific lots of Mycophenolate Mofetil for injection (500 mg/vial) because the medication failed to meet dissolution specifications—meaning the drug may not dissolve properly in the body. This could affect how well the medicine works. The recall affects two lots distributed nationwide.
ModerateFDASep 9, 2026
- Mylan acamprosate calcium tablets recalled for failed dissolution
Mylan Pharmaceuticals is recalling one lot of Acamprosate Calcium 333 mg delayed-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication as intended in the body. This could result in ineffective treatment. No injuries have been reported.
ModerateFDAAug 26, 2026
- Amnesteem isotretinoin capsules recalled for failed dissolution
Mylan Pharmaceuticals is recalling specific lots of Amnesteem (isotretinoin) 40 mg capsules because they failed to meet dissolution specifications—meaning the medication may not break down and be absorbed by your body as intended. This could affect how well the medicine works. The recall affects two lots (3116110 and 3116130) with an expiration date of July 2026.
ModerateFDAMar 11, 2026