Claravis — Class III drug recall D-0005-2017
Terminated recall by Teva North America, reported 2016-10-12, distributed nationwide. Failed Impurities/Degradation Specifications.
| Recall number | D-0005-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva North America, Horsham, PA, United States |
| Recall initiated | 2016-08-05 |
| Classified | 2016-10-05 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 3,569 capsules |
| Reason classes | specification failure |
| NDC | 00555-1054-86 |
| Lot numbers | 34025714A |
| Expiration dates | 2016-12 |
Product
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Reason for recall
Failed Impurities/Degradation Specifications.
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-0005-2017. 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.