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Drug FDA Class II Ongoing Failed specifications

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.

MYLAN PHARMACEUTICALS INC Published Mar 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact MYLAN PHARMACEUTICALS INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications

Hazards

Failed Dissolution · primary

Affected products (1)

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.

AMNESTEEM · 34850 blister packs

NDC: 0378-6611, 0378-6612, 0378-6613, 0378-6614, 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6613-85, 0378-6613-93, 0378-6614-85, 0378-6614-93
Code info: Lot #: 3116110, 3116130, Exp. Date 07/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 24, 2026
  2. Published
    Mar 11, 2026
Recall number
D-0399-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.