Mylan Pharmaceuticals Inc. recalls Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA.
Mylan recalls 80mg Sotalol tablets with metal particles. Stop using if you have these specific bottles.
Stop using this now
Presence of particulate matter. presence of metal particles.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 80mg Sotalol HCL tablets that may contain metal particles and particulate matter. This could cause serious injury if taken. The recall affects prescription bottles with specific lot numbers. Read more at govinfonow.com/recall/37339-mylan-sotalol-tablets-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/37339-mylan-sotalol-tablets-recall-particulate-matter-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-1031-2020
Cite this page
“Mylan Sotalol Tablets Recall: Particulate Matter Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37339-mylan-sotalol-tablets-recall-particulate-matter-hazard. Based on FDA recall #D-1031-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1031-2020%22&limit=1).
Why it’s dangerous
Metal particles and particulate matter in the tablets could cause serious injury if taken. These impurities might lead to blockages or other health issues when ingested.
Who’s affected
Prescription patients with the specific 80mg Sotalol tablets (NDC 00378-5123-01, Lot #3095754) are affected. Those who have taken the tablets without checking the lot number are at highest risk.
How to tell if you have this one
Check for the NDC code 00378-5123-01 and lot number 3095754 on the bottle. The tablets are prescription-only 80mg Sotalol HCL with 100 tablets per bottle.
- Brand
Mylan- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled Sotalol tablets if you have them.
Questions people ask
Why is this product being recalled?
The product contains metal particles and particulate matter that could cause serious injury if taken.
What should I do if I have the recalled product?
Stop using it immediately and contact Mylan for further instructions.
Is there a specific lot number I should check?
Yes, the recalled lot number is 3095754 with NDC 00378-5123-01.
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-1031-2020 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-1031-2020 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-1031-2020 (March 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1031-2020 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.