Mylan Pharmaceuticals Inc. recalls bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc.
Mylan is recalling 500-count bupropion XL 300mg tablets (NDC 0378-2009-05) after stability testing found impurities. This is a voluntary recall for safety.
Lower-risk recall
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 500-count bupropion XL 300mg tablets (Rx only) because routine stability testing found impurities. This could pose a safety risk if the tablets degrade over time. Read more at govinfonow.com/recall/41112-mylan-recalls-bupropion-xl-300mg-tablets-due-to-impurities-in.
Source Summary by GovInfoNow · govinfonow.com/recall/41112-mylan-recalls-bupropion-xl-300mg-tablets-due-to-impurities-in · Updated October 7, 2026 · FDA enforcement record: FDA #D-0230-2018
Cite this page
“Mylan recalls bupropion XL 300mg tablets due to impurities in stability testing.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41112-mylan-recalls-bupropion-xl-300mg-tablets-due-to-impurities-in. Based on FDA recall #D-0230-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0230-2018%22&limit=1).
Why it’s dangerous
The tablets were found to have impurities during routine stability testing. This means the medication might not be safe if it degrades over time, but the risk is low and not immediate.
Who’s affected
Prescription users of bupropion XL 300mg tablets in the US. People with a prescription for this medication are most at risk.
How to tell if you have this one
Check for the 500-count bottle labeled 'bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg'. The NDC code is 0378-2009-05. The lot number 3077281 was produced and expires June 2018.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Your Medication
Look for the 500-count bottle with NDC 0378-2009-05 and lot number 3077281.
Questions people ask
Why is this medication being recalled?
Mylan found impurities in the tablets during routine stability testing, which could affect safety if the tablets degrade over time.
Is this a dangerous hazard?
The hazard is low risk as the impurities were detected during routine testing and do not pose an immediate serious injury risk.
What should I do if I have this medication?
Check your medication for the NDC code 0378-2009-05 and lot number 3077281. If you have it, contact Mylan for guidance.
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-0230-2018 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0230-2018 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-0230-2018 (November 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0230-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.