FDA recall D-0521-2026

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 for recall

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

Distribution

Nationwide in the USA, Puerto Rico and Virgin Islands

Key facts

Status

Ongoing

Initiation date

2026-04-06

Report date

2026-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0521-2026