The Recall Desk
HighFDA (Drugs)·D-0399-2026·Announced 2026-03-11

Amnesteem isotretinoin 40 mg capsules failed dissolution specifications

Mylan Pharmaceuticals is recalling two lots of Amnesteem (Isotretinoin) Capsules 40 mg after the product failed dissolution specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the medicine may not release its dose as specified, and no injuries are stated in the source.

Plain-English summary

Mylan Pharmaceuticals Inc is recalling Amnesteem (Isotretinoin) Capsules USP, 40 mg, in 3 x 10-count prescription packs, prescription only, made in France for Mylan Pharmaceuticals Inc. of Morgantown, West Virginia, NDC 0378-6614-93. About 34,850 blister packs were distributed nationwide within the United States. The FDA has classified this recall as Class II.

The recall was initiated because the product failed dissolution specifications.

Affected product covers lots 3116110 and 3116130, both with an expiry date of 07/2026.

Patients and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Mylan Pharmaceuticals Inc for further information.

The recalled product

Product
AMNESTEEM (ISOTRETINOIN)
Brand
AMNESTEEM
Manufacturer
MYLAN PHARMACEUTICALS INC
Category
Drug — Prescription capsule
Hazard
Affected units
34,850

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #: 3116110
  • 3116130
  • Exp. Date 07/2026

Distribution

Distributed nationwide across the United States.

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