FreshRecalls

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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

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 23, 2026 at 11:04 PM UTC.

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