Invokamet — Class III drug recall D-0115-2017
Terminated recall by Janssen Ortho L.L.C., reported 2016-11-02, distributed nationwide. Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the
| Recall number | D-0115-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Janssen Ortho L.L.C., Gurabo, PR, United States |
| Recall initiated | 2016-10-19 |
| Classified | 2016-10-25 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2018-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 5,346 bottles |
| Reason classes | labeling |
| NDC | 50458-0540, 50458-0540-60, 50458-0540-91, 50458-0541, 50458-0541-60, 50458-0541-91, 50458-0542, 50458-0542-60, 50458-0542-91, 50458-0543, 50458-0543-60, 50458-0543-91, 50458-0940, 50458-0940-01, 50458-0940-02, 50458-0941, 50458-0941-01, 50458-0941-02, 50458-0942, 50458-0942-01, 50458-0942-02, 50458-0943, 50458-0943-01, 50458-0943-02 |
| Lot numbers | 09/17, 16GG581X |
Product
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60
Reason for recall
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
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-0115-2017. 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.