FDAClass II · Drug · Recalled April 29, 2026

Claravis (isotretinoin capsule recall — Teva Pharmaceuticals USA, Inc

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0521-2026
Brand: Teva Pharmaceuticals USA
Classification: Class II
Units affected: 5,101 cartons
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

Claravis (isotretinoin capsule

Companies & origin

Recalling firm location: Parsippany, NJ, United States
Firm address: 400 Interpace Pkwy Bldg A, N/A, 07054-1120

Identifying details (verbatim from the notice)

Product codes / lots: Lots#: 100067507, 100067508, Exp 07/31/2026
Distribution: Nationwide in the USA, Puerto Rico and Virgin Islands
Firm notified the public via: Letter
FDA event ID: 98730
Recall initiated: April 6, 2026
FDA classified: May 6, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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