[pending] AMNESTEEM (ISOTRETINOIN)
Pending LLM rewrite. Source: FDA_DRUG D-0399-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Failed Dissolution Specifications
The recalled product
- Product
- AMNESTEEM (ISOTRETINOIN)
- Brand
- AMNESTEEM
- Manufacturer
- MYLAN PHARMACEUTICALS INC
- Category
- Drug — Drugs
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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