Teva Pharmaceuticals Usa, Inc: Claravis (isotretinoin Capsule, Usp), 10 Mg, Packaged As A) 100-count Carton
Claravis Recall Summary Teva Pharmaceuticals is recalling Claravis (isotretinoin) 10 mg capsules in 30-count and 100-count packages nationwide because some batches contain higher-than-acceptable levels of tretinoin, a related impurity. This recall affects patients in all U.S. states and the Virgin Islands who received this acne medication.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA; Virgin Islands
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3d495a2e-ea7c-4b6b-b8e4-7778bc51aabb