Class IIOngoing

Claravis (isotretinoin capsule recall

FDA recall D-0521-2026 · initiated Apr 6, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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.
Recalling company: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA, Puerto Rico and Virgin Islands
Initiated: Apr 6, 2026
FDA report date: Apr 29, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0521-2026 ↗

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