Prescription Drug Isotretinoin Recalled Due to Over-Potent Formulation
Teva Pharmaceuticals recalls Isotretinoin 40mg capsules for exceeding specification limits in potency. No illnesses reported.
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: FDA Class II recall of a prescription drug found to exceed active ingredient specification limits. While no illnesses or injuries have been reported, the risk from a superpotent formulation of a high-risk medication justifies High severity per the rubric.
Plain-English summary
Teva Pharmaceuticals USA, Inc. has recalled one lot of Isotretinoin Capsules, USP 40mg (Lot #100044259, expiring 06/30/2025). During 3-month stability testing, the drug's assay was found to exceed the specification limit, resulting in a superpotent formulation.
The recalled product consists of 5,304 cartons distributed nationwide in the USA with NDC 0591-2436-45 (blister pack) and 0591-2436-15 (carton). No illnesses or injuries have been reported to date.
The recalled product
- Product
- ISOTRETINOIN (ISOTRETINOIN)
- Brand
- ISOTRETINOIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug
- Hazard
- superpotency
- overdose-risk
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 (2)
- Lot #: 100044259
- Exp 06/30/2025.
Distribution
Distributed nationwide across the United States.
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