FDA-Drug2026-03-11Class IIPROCESSING DEFECT
Mylan Amnesteem isotretinoin 40 mg capsules recalled for failed dissolution
What this means
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.
- Check if your Amnesteem capsules match lot #3116110 or #3116130 (printed on the blister pack).
- If you have an affected lot, stop taking the medication and contact your pharmacy or doctor.
- Do not flush or throw the medication in the trash; ask your pharmacist about safe disposal.
- Your doctor can prescribe a replacement if you need to continue treatment.
The agency's original wording
Hazard
Failed Dissolution Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
34850 blister packs
Manufactured in
1311 Pineview Dr, N/A, Morgantown, WV, United States
Products
Amnesteem (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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2026More Mylan recalls
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