Klonopin — Class III drug recall D-0416-2018
Terminated recall by Genentech, Inc., reported 2018-02-21, distributed nationwide. Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the p
| Recall number | D-0416-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech, Inc., South San Francisco, CA, United States |
| Recall initiated | 2018-02-05 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,192 bottles |
| Reason classes | labeling |
| NDC | 00004-0068-01 |
| Lot numbers | 3141989 |
| Expiration dates | 2019-08-31 |
Product
Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Reason for recall
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
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-0416-2018. 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.