FDA Drug recall D-0115-2017
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen O…
- FDA Drug
- Class III
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class III recall of Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen O… by Janssen Ortho, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0115-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-19 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Janssen Ortho |
| Distribution | US |
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
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.
Identifiers
| ndc | 50458-540-60 |
|---|---|
| ndc | 50458-540-91 |
| ndc | 50458-541-60 |
| ndc | 50458-541-91 |
| ndc | 50458-542-60 |
| ndc | 50458-542-91 |
| ndc | 50458-543-60 |
| ndc | 50458-543-91 |
| ndc | 50458-940-01 |
| ndc | 50458-940-02 |
| ndc | 50458-941-01 |
| ndc | 50458-941-02 |
| ndc | 50458-942-01 |
| ndc | 50458-942-02 |
| ndc | 50458-943-01 |
| ndc | 50458-943-02 |
| code_info | Lot #: 16GG581X, Exp 09/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0115-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.