Mylan Clonazepam Tablets Recall: Impurity Risk in 1.0 mg Dose
Mylan recalls 1.0 mg Clonazepam tablets with impurity issues. Affected lots expired by 2017. Stop using if you have these specific packaging details.
Recall notice
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Contact the company
What happened, in plain English
Mylan is recalling 1.0 mg Clonazepam tablets that may contain an impurity. This could pose a risk to users, though the exact danger level isn't specified in the recall notice. Read more at govinfonow.com/recall/42304-mylan-clonazepam-tablets-recall-impurity-risk-in-1-0-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/42304-mylan-clonazepam-tablets-recall-impurity-risk-in-1-0-mg · Updated October 9, 2026 · FDA enforcement record: FDA #D-0136-2017
Cite this page
“Mylan Clonazepam Tablets Recall: Impurity Risk in 1.0 mg Dose.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42304-mylan-clonazepam-tablets-recall-impurity-risk-in-1-0-mg. Based on FDA recall #D-0136-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0136-2017%22&limit=1).
Why it’s dangerous
The tablets may contain a known impurity (Clonazepam Related Compound A) that exceeds safe levels at 16 months. This impurity could potentially cause health issues, though the exact risk isn't detailed in the recall.
Who’s affected
Prescription users of the 1.0 mg Clonazepam tablets with the specific lot numbers and expiration dates listed. People who have these tablets and are taking them for medical reasons are most at risk.
How to tell if you have this one
Check for the 100-count unit dose box with 10 x 10 blister cards. Look for lot numbers 3061784 (exp 11/16), 3067656 (exp 12/16), or 3074902 (exp 08/17).
- Brand
Mylan- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0135-2017 | Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505; Lot#: a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17 | 1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each) |
| D-0136-2017 | Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20; Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17 | 46,472 unit dose blister cards (10 cards of 10 tablets each) |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the packaging to confirm if your tablets are affected.
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 23 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-0136-2017 (September 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0136-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.