Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a)… was recalled on April 6, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin.
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.
Lots#: 100067507, 100067508, Exp 07/31/2026
Units affected: 5,101 cartons
Where it was sold: Nationwide in the USA, Puerto Rico and Virgin Islands
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Teva Pharmaceuticals USA, Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
View official notice →The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
Be the first to know when products like this are recalled. Free weekly digest, unsubscribe anytime.