Teva Pharmaceuticals Usa, Inc: Claravis (isotretinoin Capsule, Usp), 10 Mg, Packaged As A) 100-count Carton
Claravis Recall Summary Teva Pharmaceuticals is recalling certain batches of Claravis (isotretinoin) 10 mg capsules nationwide because they contain higher-than-allowed levels of tretinoin, a related impurity. The recall affects 100-count and 30-count cartons distributed across all U.S. states, Puerto Rico, and the Virgin Islands. This is classified as a Class II recall, meaning the product could cause adverse health effects.
- 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
- Classification
- Class II
- 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, Puerto Rico and Virgin Islands
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/2d04705c-82d0-42ef-9754-cbf8c52bf98e