CLASS III Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Klonopin (clonazepam) recalled by Genentech
Genentech is recalling Klonopin (clonazepam) 0, distributed nationwide in the US. The recall was initiated on 5 Feb 2018 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-0416-2018
- FDA event ID
- 79175
- Recalling firm
- Genentech, South San Francisco, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Feb 2018
- FDA classified
- 13 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 5 Feb 2018 | Recall initiated by company | |
| 13 Feb 2018 | Classified by FDA | +8 days |
| 21 Feb 2018 | 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: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Product as listed by the FDA
Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Where it was distributed
Distributed throughout the United States
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Which lots are affected?
Lot # 3141989, EXP 08/31/2019
Where was it sold?
Distributed throughout the United States
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 Genentech
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cathflo activase (Alteplase), 2mg vials recalled by GenentechCathflo Activase | Genentech | Sterility | Nationwide |
| Drug | CLASS III | Susvimo (ranibizumab injection), 100mg/mL recalled by GenentechSusvimo | Genentech | Other | Nationwide |
| Drug | CLASS II | Xolair (omalizumab) Injection, 150 mg/, 1 prefilled syringe recalledXolair | Genentech | Potency & Assay | Nationwide |
| Drug | CLASS III | Evrysdi (risdiplam) for oral solution, 60 mg recalled by Genentech | Genentech | Other | Nationwide |
| Drug | CLASS I | Activase (alteplase), 100 mg (58 million IU) recalled by Genentech | Genentech | Foreign Material | Nationwide |