Drug recall D-0521-2026
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 for recall
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Lots and codes
Lots#: 100067507, 100067508, Exp 07/31/2026
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 5,101 cartons
- Distribution
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 6, 2026
Related products
- Claravis – drug information
- NDC 0555-1056 Claravis · Isotretinoin 30 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0555-1057 Claravis · Isotretinoin 40 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0555-1055 Claravis · Isotretinoin 20 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0555-1054 Claravis · Isotretinoin 10 mg/1 · Teva Pharmaceuticals USA, Inc.