Genentech Klonopin 0.5mg Tablets Recall: Missing Schedule IV Label
Genentech recalls 0.5mg Klonopin tablets due to missing Schedule IV controlled substance label on packaging. This could lead to improper use or diversion. Check your product details and contact Genentech for instructions.
Lower-risk recall
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Contact the company
What happened, in plain English
Genentech is recalling 0.5 mg Klonopin tablets because the product carton lacks the required Schedule IV controlled substance label. This labeling error could result in improper use or potential diversion of the medication. Read more at govinfonow.com/recall/40887-genentech-klonopin-0-5mg-tablets-recall-missing-schedule-iv-label.
Source Summary by GovInfoNow · govinfonow.com/recall/40887-genentech-klonopin-0-5mg-tablets-recall-missing-schedule-iv-label · Updated October 7, 2026 · FDA enforcement record: FDA #D-0416-2018
Cite this page
“Genentech Klonopin 0.5mg Tablets Recall: Missing Schedule IV Label.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40887-genentech-klonopin-0-5mg-tablets-recall-missing-schedule-iv-label. Based on FDA recall #D-0416-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0416-2018%22&limit=1).
Why it’s dangerous
The product carton does not include the Schedule IV controlled substance indicator, which is required by law. This labeling omission could lead to improper use or potential diversion of the medication, though the risk of serious injury is minimal.
Who’s affected
People with a prescription for Klonopin 0.5 mg tablets, 100-count bottles made in Canada and distributed by Genentech USA. Those who have the product without the correct label are most at risk.
How to tell if you have this one
Check for Klonopin 0.5 mg tablets in 100-count bottles with NDC 0004-0068-01, manufactured in Canada, and distributed by Genentech USA. The product may have a missing Schedule IV label on the carton.
- Brand
Genentech- Category
Drug
What to do — step by step
Check Product Label
Look for the missing Schedule IV controlled substance indicator on the product carton.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed throughout the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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.
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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-0416-2018 (February 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0416-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.