Notice names this product. Teva Pharmaceuticals USA’s Claravis (isotretinoin capsule is named in FDA Class II recall D-0521-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Identifying details: Lots#: 100067507, 100067508, Exp 07/31/2026. Units affected: 5,101 cartons. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Company / brand: Teva Pharmaceuticals USA recalls
Affected product: Claravis (isotretinoin capsule recall status
Official ID D-0521-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.