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Moderate riskFDA DrugClass II

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.

From the FDA notice · Read the official notice ↗ · All Mylan recalls

What to do

  1. Check if your Amnesteem capsules match lot #3116110 or #3116130 (printed on the blister pack).
  2. If you have an affected lot, stop taking the medication and contact your pharmacy or doctor.
  3. Do not flush or throw the medication in the trash; ask your pharmacist about safe disposal.
  4. Your doctor can prescribe a replacement if you need to continue treatment.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
34850 blister packs
Illnesses reported
None reported
Manufactured in
1311 Pineview Dr, N/A, Morgantown, WV, United States
Classification
Class II
Recall number
D-0399-2026

In the FDA's words

Description
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. Failed Dissolution Specifications Lot #: 3116110, 3116130, Exp. Date 07/2026 Distribution: Nationwide within the United States Affected quantity: 34850 blister packs
Hazard
Failed Dissolution Specifications

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