FDA DrugClass IINotable

FDA Recall: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with

Date: 2026-04-29
Brand: Teva Pharmaceuticals USA, Inc
Category: Drug
FDA Class: Class II

Description

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

Hazard

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

Remedy

5,101 cartons

View original recall →
Share:

Related Recalls

2026-04-15 · FDA_DRUG
FDA Recall: Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharm
Teva Pharmaceuticals USA, Inc
2026-04-15 · FDA_DRUG
FDA Recall: Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharm
Teva Pharmaceuticals USA, Inc
2026-04-15 · FDA_DRUG
FDA Recall: Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Cover
Teva Pharmaceuticals USA, Inc
2026-04-15 · FDA_DRUG
FDA Recall: Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Cover
Teva Pharmaceuticals USA, Inc