Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown,
Mylan recalls 0.25mg alprazolam tablets with elevated impurities detected during stability testing. Affected lots expire May 2019. No specific remedy stated in official notice.
Recall notice
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 0.25mg alprazolam tablets that showed elevated impurity levels during stability testing. This could pose a risk to users, though the official notice doesn't specify how serious the risk is or what to do. Read more at govinfonow.com/recall/39237-mylan-alprazolam-tablets-recall-impurity-risk-in-0-25mg-dose.
Source Summary by GovInfoNow · govinfonow.com/recall/39237-mylan-alprazolam-tablets-recall-impurity-risk-in-0-25mg-dose · Updated October 5, 2026 · FDA enforcement record: FDA #D-1013-2019
Cite this page
“Mylan Alprazolam Tablets Recall: Impurity Risk in 0.25mg Dose.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39237-mylan-alprazolam-tablets-recall-impurity-risk-in-0-25mg-dose. Based on FDA recall #D-1013-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1013-2019%22&limit=1).
Why it’s dangerous
The tablets showed elevated levels of a known impurity during a 6-month stability test. This could potentially affect the safety of the medication, though the exact health risk isn't specified in the recall notice.
Who’s affected
Prescription users of the specific lot numbers listed in the recall notice. People with medical conditions requiring alprazolam may be at higher risk if the impurities affect drug safety.
How to tell if you have this one
Check for the NDC code 51079-788-20 and lot numbers 3095198, 3096266, or 3098776 on the packaging. These tablets were manufactured for Mylan Pharmaceuticals Inc. in Morgantown, WV and expire May 2019.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Packaging Details
Look for NDC code 51079-788-20 and lot numbers 3095198, 3096266, or 3098776 on the tablet packaging.
Questions people ask
Is there a specific remedy for these tablets?
The official recall notice does not state any remedy for these tablets.
What is the risk of using these tablets?
The recall mentions elevated impurity levels detected during stability testing, but does not specify the health risk.
How can I tell if I have the recalled tablets?
Check for NDC code 51079-788-20 and lot numbers 3095198, 3096266, or 3098776 on the packaging.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-1013-2019 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-1013-2019 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1013-2019 (January 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1013-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.