Mylan recalls 40mg Isotretinoin capsules with failed dissolution specs. Check NDC 0378-6614-93, lots 3116110/311: 3x10-count packs expiring 07/2026.
Failed Dissolution Specifications
Mylan is recalling 40mg Isotretinoin capsules that failed dissolution tests. This means the medication may not work as intended for acne treatment. Patients should contact their doctor for alternatives.
The capsules failed dissolution specifications, meaning they may not release the medication properly in the body. This could lead to ineffective treatment for acne. However, the recall does not indicate immediate harm to users.
Prescription patients using the recalled Amnesteem capsules. Those with active acne treatment plans are most at risk.
Check for NDC 0378-6614-93 on the packaging. The capsules come in 3 x 10-count prescription packs with lot numbers 3116110 or 3116130, expiring 07/2026.
Look for NDC 0378-6614-93 on the packaging of the 3 x 10-count prescription packs.
The capsules failed dissolution specifications, meaning they may not release medication properly.
Check the NDC code and lot numbers on the packaging. Contact your doctor for alternative treatment options.
The recall does not indicate a risk of serious injury; the issue is about treatment effectiveness.
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0399-2026 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0399-2026 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
