Genentech Cotellic Tablets Recall: Oversized Tablet Hazard
Genentech recalls 20mg cobimetinib tablets with an oversized tablet found in the bottle. This could cause incorrect dosing if taken. Contact Genentech for details.
Lower-risk recall
Superpotent Drug: An oversized tablet was found in a bottle.
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What happened, in plain English
Genentech is recalling Cotellic (cobimetinib) tablets due to an oversized tablet found in the bottle. This could lead to incorrect dosing if taken by patients. The recall affects prescription-only tablets sold in the U.S. from specific dates. Read more at govinfonow.com/recall/41813-genentech-cotellic-tablets-recall-oversized-tablet-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/41813-genentech-cotellic-tablets-recall-oversized-tablet-hazard · Updated October 8, 2026 · FDA enforcement record: FDA #D-0648-2017
Cite this page
“Genentech Cotellic Tablets Recall: Oversized Tablet Hazard.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41813-genentech-cotellic-tablets-recall-oversized-tablet-hazard. Based on FDA recall #D-0648-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0648-2017%22&limit=1).
Why it’s dangerous
An oversized tablet was found in the bottle, which could lead to incorrect dosing if taken. This is a medication safety issue for patients using the prescription drug.
Who’s affected
Prescription patients using Cotellic (cobimetinib) tablets for cancer treatment. Those with the specific bottle label and expiration date are most at risk.
How to tell if you have this one
Check for the bottle label: 'Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland.' Also look for the expiration date on the bottle (02/18 or 02/19).
- Brand
Genentech- Product
Genentech Inc. recalls Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA- Category
Drug
What to do — step by step
Check Your Bottle
Look for the label: 'Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland.'
Contact Genentech
Reach out to Genentech for specific instructions on what to do with the recalled product.
Where it went and when
Where it was distributed
Distributed in Illinois and New Jersey.
FDA distribution: “NJ and IL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, New Jersey.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0648-2017 (March 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0648-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.