FDAHealthApril 6, 2026
Teva Pharmaceuticals USA, Inc — Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-
⚠️ Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 6, 2026
Nationwide in the USA, Puerto Rico and Virgin Islands
What's affected?
- Product
- Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Brand
- CLARAVIS
- Lot code
- #:
Additional details
Lots#: 100067507, 100067508, Exp 07/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5,101 cartons.
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