Mylan Clonazepam Recall: Impurity Issue in 0.5 mg Tablets
Mylan recalls Clonazepam Tablets, USP, 0.5 mg due to failed impurity specifications. Check your lot number and expiration date for affected units.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Contact the company
What happened, in plain English
Mylan Institutional, Inc. is recalling a specific batch of Clonazepam Tablets, USP, 0.5 mg because they contain out-of-specification levels of known impurities. This issue was identified at the six-month timepoint during quality testing. The recall affects 868 unit cartons distributed nationwide. Read more at govinfonow.com/recall/43203-mylan-clonazepam-recall-impurity-issue-in-0-5-mg-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/43203-mylan-clonazepam-recall-impurity-issue-in-0-5-mg-tablets · Updated October 11, 2026 · FDA enforcement record: FDA #D-0650-2016
Cite this page
“Mylan Clonazepam Recall: Impurity Issue in 0.5 mg Tablets.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43203-mylan-clonazepam-recall-impurity-issue-in-0-5-mg-tablets. Based on FDA recall #D-0650-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0650-2016%22&limit=1).
Why it’s dangerous
The tablets failed to meet specifications for known impurities at the six-month mark. While the specific health impact of these impurities is not detailed in the record, taking medication with incorrect chemical composition can affect its safety and efficacy.
Who’s affected
Patients currently taking Clonazepam Tablets, USP, 0.5 mg who purchased the affected product from pharmacies or healthcare providers across the United States.
How to tell if you have this one
Look for Clonazepam Tablets, USP, 0.5 mg in a 100-count carton. The product was manufactured by Mylan Pharmaceuticals Inc. in Morgantown, WV. Affected units have NDC: 51079-881-21, Lot # 3063759, and an expiration date of 07/16.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Clonazepam tablets match NDC: 51079-881-21, Lot # 3063759, and Exp. 07/16.
Contact Your Pharmacist
If you have the affected lot, contact your pharmacist or healthcare provider for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 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-0650-2016 (January 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0650-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.