CLASS II Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Cotellic (cobimetinib) Tablets, 20 mg recalled by Genentech
Genentech is recalling Cotellic (cobimetinib) Tablets, 20 mg, distributed in Illinois, New Jersey. The recall was initiated on 13 Mar 2017 and the FDA has classified it as Class II.
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-0648-2017
- FDA event ID
- 76726
- Recalling firm
- Genentech, South San Francisco, CA
- Brand
- Cotellic
- Manufacturer
- Genentech, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2017
- FDA classified
- 5 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Mar 2017 | Recall initiated by company | |
| 5 Apr 2017 | Classified by FDA | +23 days |
| 12 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: An oversized tablet was found in a bottle.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.
Where it was distributed
NJ and IL
Questions about this recall
Why was it recalled?
Superpotent Drug: An oversized tablet was found in a bottle.
Which lots are affected?
B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
Where was it sold?
NJ and IL
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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