United StatesClaravis (isotretinoin capsule, USP) 10 mg packaged as a 100‑count carton (NDC 0555-1054-56 with 10x10 blister NDC 0555-1054-60) and a 30‑count carton (NDC 0555-1054-86 with 3x10 blister NDC 0555-1054-60), Lot 100067507 and 100067508, exp 07/31/2026, is recalled. The recall was issued because the product tested out of specification for a specific impurity, tretinoin. The recall is ongoing and covers 5,101 cartons distributed nationwide in the USA, Puerto Rico and the U.S. Virgin Islands.
What's being recalled
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.
Recalling firm: Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States.
How to identify it
Lots#: 100067507, 100067508, Exp 07/31/2026
The hazard
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA, Puerto Rico and Virgin Islands
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)