Mylan Recalls Bupropion HCL 300 mg Tablets Due to Impurities
Mylan Pharmaceuticals is recalling specific lots of 300 mg extended-release bupropion tablets due to failed impurity specifications from stability testing.
Recall notice
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
What happened, in plain English
Mylan Pharmaceuticals Inc. is voluntarily recalling one lot of Bupropion HCL Extended-Release Tablets, USP (XL) 300 mg because the product failed impurity specifications during routine stability testing. The recall affects 1,414 bottles distributed nationwide in the USA. The record does not specify any injuries or a remedy for consumers. Read more at govinfonow.com/recall/41112-mylan-recalls-bupropion-hcl-300-mg-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/41112-mylan-recalls-bupropion-hcl-300-mg-tablets-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0230-2018
Cite this page
“Mylan Recalls Bupropion HCL 300 mg Tablets Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41112-mylan-recalls-bupropion-hcl-300-mg-tablets-due-to-impurities. 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 hazard is that the tablets contain related compounds outside of specification limits due to degradation or impurities. The record does not describe what these impurities are or how they might affect health, so the danger mechanism is unclear.
Who’s affected
Patients in the USA who have been prescribed this specific medication by Mylan Pharmaceuticals Inc. are affected. No specific risk group is identified in the record beyond those possessing the recalled product.
How to tell if you have this one
Check your medication bottle for the brand Mylan Pharmaceuticals Inc., NDC 0378-2009-05, Lot # 3077281, and an expiration date of 06-2018. The product is Bupropion HCL Extended-Release Tablets, USP (XL) 300 mg in a 500-count bottle.
- Brand
Mylan- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Mylan recalls
Latest drug recalls
Keep exploring
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 qwen3.6:35b-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.