FDAFDA · Food and drugs·Recall number D-0521-2026
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.
Published April 29, 2026 · Recall initiated: April 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLARAVIS
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Lot
- Lots#: 100067507, 100067508, Exp 07/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.