Cotellic — Class II drug recall D-0648-2017
Terminated recall by Genentech Inc., reported 2017-04-12, distributed in IL, NJ. Superpotent Drug: An oversized tablet was found in a bottle.
| Recall number | D-0648-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech Inc., South San Francisco, CA, United States |
| Recall initiated | 2017-03-13 |
| Classified | 2017-04-05 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2017-05-12 |
| Distributed | IL, NJ |
| Quantity | 748 bottles |
| Reason classes | potency |
| NDC | 50242-0717, 50242-0717-01 |
Product
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.
Reason for recall
Superpotent Drug: An oversized tablet was found in a bottle.
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-0648-2017. 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.