Claravis recall (Teva Pharmaceuticals USA, Inc)
DrugClass IIOngoing
Summary: Teva Pharmaceuticals USA, Inc is recalling 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.
What is 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.
Why
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA, Puerto Rico and Virgin Islands (states named: Puerto Rico)
How to tell if yours is affected
Lots#: 100067507, 100067508, Exp 07/31/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0521-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 6, 2026 |
| Reported | April 29, 2026 |
| Company | Teva Pharmaceuticals USA, Inc |
| Company location | Parsippany, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5,101 cartons |
More recalls from Teva Pharmaceuticals USA, Inc · all drug recalls · recalls from April 2026