⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Teva Pharmaceuticals USA, Inc: 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

DrugsSource: FDA (drug) · Date: 2026-04-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Teva Pharmaceuticals USA, Inc
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.
Reason / hazard
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA, Puerto Rico and Virgin Islands
Recall initiated
2026-04-06
Code info
Lots#: 100067507, 100067508, Exp 07/31/2026
Product quantity
5,101 cartons
Voluntary mandated
Voluntary: Firm initiated
City
Parsippany
State
NJ
Country
United States
Event id
98730
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