Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
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Contact the company
📍Recalling firmMylan Institutional, Inc. (d.b.a. UDL Laboratories)1718 Northrock Ct · Rockford, IL 61103-1201
✎ GovInfoNow plain-language explainer
Mylan Institutional, Inc. is recalling specific lots of Alprazolam Tablets, USP, 0.25 mg because they contain elevated levels of a known impurity. This issue was detected during stability testing for the product's shelf life. The recall covers 10,281 units distributed nationwide. Read more at govinfonow.com/recall/39237-mylan-alprazolam-0-25mg-recall-impurity-risk.
“Mylan Alprazolam 0.25mg Recall: Impurity Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39237-mylan-alprazolam-0-25mg-recall-impurity-risk. Based on FDA recall #D-1013-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1013-2019%22&limit=1).
The FDA announced on Jan. 18, 2019, that Mylan Institutional, Inc. (d.b.a. UDL Laboratories) voluntarily recalled Alprazolam Tablets, USP, 0.25 mg due to elevated levels of a known impurity. The recall affects 10,281 cartons distributed nationwide and in Puerto Rico.
How to tell if you have it
Brand: Mylan
Product: Alprazolam Tablets, USP, 0.25 mg
NDC: 51079-788-20
Lots: 3095198, 3096266, 3098776
Expiration: 05-2019
Quantity: 10x10 per carton
The hazard
According to the FDA, elevated levels of a known impurity were detected during the 6-month room temperature stability interval. The company classified the recall as Class II.
Context
GovInfoNow's records show Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has had 15 other recalls since Dec. 14, 2012. Other recent recalls of similar products include Mylan Esomeprazole Capsules Recall on April 1, 2022, and Mylan Diltiazem Capsules Recall on Aug. 14, 2018. Additional context includes the Loxapine Capsules recall on May 1, 2018, due to GMP deviations.
How to tell if you have this one
Check your medication carton for NDC 51079-788-20 and one of the following lot numbers: 3095198, 3096266, or 3098776. Verify that the expiration date is 05-2019. The product is manufactured for Mylan Pharmaceuticals Inc. in Morgantown, WV.
Brand
Mylan
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check your medication details
Verify if your Alprazolam Tablets have NDC 51079-788-20 and lot numbers 3095198, 3096266, or 3098776 with an expiration date of 05-2019.
Contact your pharmacist
If you have the recalled product, speak with your pharmacist or healthcare provider immediately to discuss replacement options.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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 qwen3.6:35b-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.