drugs MODERATE Updated 2026-03-11

MYLAN PHARMACEUTICALS INC recalls Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3

See all recalls from MYLAN PHARMACEUTICALS INC →

Recalled 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.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

Failed Dissolution Specifications

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 3116110, 3116130, Exp. Date 07/2026

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall