FDA Drug recall D-0521-2026
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60
- FDA Drug
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60 by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0521-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-06 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Identifiers
| ndc | 0555-1054-60 |
|---|---|
| ndc | 0555-1054-86 |
| ndc | 0555-1054-56 |
| ndc | 0555-1055-60 |
| ndc | 0555-1055-86 |
| ndc | 0555-1055-56 |
| ndc | 0555-1056-60 |
| ndc | 0555-1056-86 |
| ndc | 0555-1057-60 |
| ndc | 0555-1057-56 |
| ndc | 0555-1057-86 |
| code_info | Lots#: 100067507, 100067508, Exp 07/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0521-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.