FDA Drugs recall ·
Claravis (isotretinoin capsule, USP), 10 mg… recall
- Recall number
- D-0521-2026
- Date
- (initiated April 6, 2026)
- Company / brand
- Teva Pharmaceuticals USA, Inc
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,101 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots#: 100067507, 100067508, Exp 07/31/2026
Distribution
Nationwide in the USA, Puerto Rico and Virgin Islands
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0521-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.