Claravis — Class II drug recall D-0521-2026
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2026-04-29, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
| Recall number | D-0521-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2026-04-06 |
| Classified | 2026-05-06 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 5,101 cartons |
| Reason classes | specification failure |
| NDC | 00555-1054, 00555-1054-56, 00555-1054-60, 00555-1054-86, 00555-1055, 00555-1055-56, 00555-1055-60, 00555-1055-86, 00555-1056, 00555-1056-60, 00555-1056-86, 00555-1057, 00555-1057-56, 00555-1057-60, 00555-1057-86 |
| Lot numbers | 100067507, 100067508 |
| Expiration dates | 2026-07-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0521-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.