Teva Pharmaceuticals USA, Inc recalls Claravis
- Recalling company
- Teva Pharmaceuticals USA, Inc
- 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.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 6, 2026
- Reported
- Apr 29, 2026
- Distribution
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Status
- Ongoing
- Quantity
- 5,101 cartons
- Lot / codes
- Lots#: 100067507, 100067508, Exp 07/31/2026
- Company location
- Parsippany, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0521-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0521-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.