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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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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