Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My
Summary
The FDA issued a Class II for Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescript by MYLAN PHARMACEUTICALS INC. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-0399-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #: 3116110, 3116130, Exp. Date 07/2026
Quantity Affected: 34850 blister packs
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-24
Company
Morgantown, WV
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
MYLAN PHARMACEUTICALS INC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MYLAN PHARMACEUTICALS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MYLAN PHARMACEUTICALS INC have FDA actions?
MYLAN PHARMACEUTICALS INC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0399-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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