Tarceva — Class II drug recall D-0008-2015
Terminated recall by Astellas Pharma US Inc, reported 2014-10-15, distributed nationwide. Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test d
| Recall number | D-0008-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Astellas Pharma US Inc, Northbrook, IL, United States |
| Recall initiated | 2014-09-15 |
| Classified | 2014-10-07 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 9,236 bottles |
| Reason classes | specification failure |
| NDC | 50242-0064-01 |
| Lot numbers | 04/16, 66482CW |
Product
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Reason for recall
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
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-0008-2015. 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.