April 2026 FDA Recall Claravis by Teva Pharmaceuticals Usa, Inc
D-0521-2026 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on April 6, 2026 for the product Claravis. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0521-2026
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
04-06-2026
04-29-2026
5,101 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA, Puerto Rico and Virgin Islands
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lots#: 100067507, 100067508, Exp 07/31/2026
