Mylan Pharmaceuticals Inc. recalls Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV
Mylan recalls 500-count Alprazolam tablets (0.5mg) manufactured in Australia with foreign substance. Affected lots expire September 2020. Consumers should contact Mylan for details.
Recall notice
Presence of Foreign Substance
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 500-count Alprazolam tablets (0.5mg) due to a foreign substance found in some batches. This recall affects prescription-only medication sold in the US. The foreign substance could cause harm if taken. Read more at govinfonow.com/recall/37798-mylan-alprazolam-tablets-0-5mg-recall-foreign-substance-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/37798-mylan-alprazolam-tablets-0-5mg-recall-foreign-substance-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-0186-2020
Cite this page
“Mylan Alprazolam Tablets 0.5mg Recall: Foreign Substance Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37798-mylan-alprazolam-tablets-0-5mg-recall-foreign-substance-hazard. Based on FDA recall #D-0186-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0186-2020%22&limit=1).
Why it’s dangerous
The presence of a foreign substance in the tablets could cause harm if taken. This is a medication safety issue that requires immediate attention to prevent potential health risks.
Who’s affected
Prescription holders of Alprazolam tablets (0.5mg) with NDC 0378-4003-05 and lot number 8082708. People taking these medications for anxiety or related conditions are at risk.
How to tell if you have this one
Check for the NDC code 0378-4003-05 and lot number 8082708 on the bottle. The tablets were manufactured in Australia and expire September 2020.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 0378-4003-05 and lot number 8082708 on the bottle label.
Questions people ask
Is this product safe to use?
The recall states a foreign substance is present, so it is not safe to use. Consumers should stop using and contact Mylan for instructions.
What should I do if I have this product?
Contact Mylan Pharmaceuticals directly for specific instructions on what to do with the recalled product.
When was this product made?
The product was manufactured in Australia and expires September 2020.
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-0186-2020 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0186-2020 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-0186-2020 (October 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0186-2020 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.