Claravis Capsule, Liquid Filled
FDA Recall NDC 0555-1055
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Claravis (NDC 0555-1055). A significant event, classified as Class II, was initiated on Apr 06, 2026 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Apr 06, 2026
Apr 29, 2026
5,101 cartons
Recall Profile & Regulatory Data
Event ID
98730
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA, Puerto Rico and Virgin Islands
Product 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.
Batch or Lot Expiration Information
Lot# Lots#: 100067507, 100067508, Exp 07/31/2026
Affected Packages Involved in this Recall
0555-1054-60Product
0555-1054-86Product
0555-1054-56Product
0555-1055-60Product
0555-1055-86Product
0555-1055-56Product
0555-1056-60Product
0555-1056-86Product
0555-1057-60Product
0555-1057-56Product
0555-1057-86Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
