CLASS III Drug recall · Reported 2 Nov 2016 · FDA Enforcement Report
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg recalled
Janssen Ortho is recalling Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, distributed nationwide in the US. The recall was initiated on 19 Oct 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0115-2017
- FDA event ID
- 75449
- Recalling firm
- Janssen Ortho, Gurabo, PR
- Brand
- Invokamet
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Oct 2016
- FDA classified
- 25 Oct 2016
- Reported
- 2 Nov 2016
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 19 Oct 2016 | Recall initiated by company | |
| 25 Oct 2016 | Classified by FDA | +6 days |
| 2 Nov 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 16GG581X, Exp 09/17
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Janssen Ortho
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xarelto (rivaroxaban) Tablets recalled by Janssen Ortho | Janssen Ortho | Sterility | Nationwide |