Amnesteem Capsule
FDA Recall NDC 0378-6613
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Amnesteem (NDC 0378-6613). A significant event, classified as Class II, was initiated on Feb 24, 2026 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Feb 24, 2026
Mar 11, 2026
34850 blister packs
Recall Profile & Regulatory Data
Event ID
98477
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MYLAN PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product 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.
Batch or Lot Expiration Information
Lot# : 3116110, 3116130, Exp. Date 07/2026
Affected Packages Involved in this Recall
0378-6611-85Product
0378-6611-93Product
0378-6612-85Product
0378-6612-93Product
0378-6613-85Product
0378-6613-93Product
0378-6614-85Product
0378-6614-93Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
