Janssen Invokamet Tablets Recall: Missing Prescribing Information
Janssen recalls Invokamet 150/1000 mg tablets due to incorrect or missing prescribing information labels. Affected units may have Xarelto outserts instead of Invokamet instructions.
Lower-risk 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.
Contact the company
What happened, in plain English
Janssen is recalling Invokamet tablets because some packages have Xarelto prescribing information instead of the correct Invokamet instructions. This could lead to incorrect medication use if patients rely on the wrong label. Read more at govinfonow.com/recall/42289-janssen-invokamet-tablets-recall-missing-prescribing-information.
Source Summary by GovInfoNow · govinfonow.com/recall/42289-janssen-invokamet-tablets-recall-missing-prescribing-information · Updated October 9, 2026 · FDA enforcement record: FDA #D-0115-2017
Cite this page
“Janssen Invokamet Tablets Recall: Missing Prescribing Information.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42289-janssen-invokamet-tablets-recall-missing-prescribing-information. Based on FDA recall #D-0115-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0115-2017%22&limit=1).
Why it’s dangerous
The hazard involves incorrect or missing prescribing information labels. Some Invokamet bottles may have Xarelto's prescribing information outserts instead of the correct Invokamet instructions. This could lead to patients using the wrong medication information.
Who’s affected
Prescription holders of Invokamet 150/1000 mg tablets with the specific lot number 16GG581X (expiring 09/17) are affected. Patients using these tablets may be at risk of incorrect medication use due to the missing or incorrect labeling.
How to tell if you have this one
Check for Invokamet tablets with a 60-count bottle, 150 mg/1000 mg strength, and lot number 16GG581X (expiring 09/17). The package may show Xarelto prescribing information instead of Invokamet instructions.
- Brand
Janssen- Category
Drug
What to do — step by step
Check Label
Look for Xarelto prescribing information outserts instead of Invokamet instructions on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
The recall does not require immediate action beyond checking the label. If you see Xarelto information instead of Invokamet instructions, contact your doctor or pharmacist.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0115-2017 (October 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0115-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.