CLASS III Drug recall · Reported 10 Feb 2016 · FDA Enforcement Report
Clonazepam Tablets, USP, 0.5 mg recalled by Mylan Institutional, Inc.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Clonazepam Tablets, USP, 0.5 mg, distributed nationwide in the US. The recall was initiated on 28 Jan 2016 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-0650-2016
- FDA event ID
- 73170
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jan 2016
- FDA classified
- 2 Feb 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 28 Jan 2016 | Recall initiated by company | |
| 2 Feb 2016 | Classified by FDA | +5 days |
| 10 Feb 2016 | 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
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
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
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Which lots are affected?
Lot # 3063759, Exp.07/16
Where was it sold?
Nationwide
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 Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other Clonazepam recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets recalledClonazepam | Endo Pharmaceuticals | Labeling Errors | Nationwide |