US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Apr 6, 2026 (5 months ago)

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

What was 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
NDC code
0555-1054-56
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0521-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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