Recall: D-0521-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-06Initiated

OngoingStatus

Teva Pharmaceuticals USA, IncFirm

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

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

Distribution

Nationwide in the USA, Puerto Rico and Virgin Islands

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.