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Class II · ModerateActive recall

Amnesteem

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 3116110, 3116130, Exp. Date 07/2026
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in France
Brand nameAMNESTEEM
Generic nameISOTRETINOIN
Active ingredient(s)ISOTRETINOIN
Distributed by / forMylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France
NDC0378-6614-93
Show the full FDA record
Full product labelAmnesteem (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.
Recalling firmMYLAN PHARMACEUTICALS INC
DistributionNationwide within the United States
Quantity34850 blister packs
Recall initiated2026-02-24
Report date2026-03-11
Recall completed—
Recall numberD-0399-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMorgantown WV United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.