InvaGen Pharmaceuticals, Inc. recalls Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for:
InvaGen Pharmaceuticals recalls 150mg Bupropion ER tablets with impurities from batches older than 18 months. These tablets may contain harmful levels of meta-chlorobenzoic acid, posing a risk of serious injury if taken.
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Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
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What happened, in plain English
InvaGen Pharmaceuticals is recalling 150mg Bupropion Hydrochloride ER tablets that were manufactured for more than 18 months ago. These tablets may contain harmful impurities that could cause serious injury if taken. Read more at govinfonow.com/recall/39656-invagen-bupropion-er-tablets-recall-impurities-risk-serious-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/39656-invagen-bupropion-er-tablets-recall-impurities-risk-serious-injury · Updated October 6, 2026 · FDA enforcement record: FDA #D-1212-2018
Cite this page
“InvaGen Bupropion ER Tablets Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39656-invagen-bupropion-er-tablets-recall-impurities-risk-serious-injury. Based on FDA recall #D-1212-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1212-2018%22&limit=1).
Why it’s dangerous
The tablets may contain harmful levels of meta-chlorobenzoic acid impurities due to degradation over time. This impurity can cause serious injury if the medication is taken as intended, particularly in patients using it for depression treatment.
Who’s affected
People who own or use the recalled 150mg Bupropion ER tablets in 90-count bottles with specific lot numbers and expiration dates listed in the recall notice are most at risk. This includes patients taking the medication for depression or other conditions.
How to tell if you have this one
Check for 90-count bottles labeled with NDC 69097-875-05 or 68001-322-05. The lot numbers and expiration dates listed in the recall notice indicate which batches are affected.
- Brand
InvaGen- Category
Drug
What to do — step by step
Stop using it now
Immediately stop taking the recalled Bupropion ER tablets and contact your healthcare provider for alternative treatment options.
Questions people ask
What specific tablets are being recalled?
The recalled tablets are 150mg Bupropion Hydrochloride ER tablets in 90-count bottles with specific lot numbers and expiration dates listed in the recall notice.
How can I tell if I have the recalled tablets?
Check for 90-count bottles labeled with NDC 69097-875-05 or 68001-322-05, and verify the lot numbers and expiration dates against the list provided in the recall notice.
What should I do if I have the recalled tablets?
Immediately stop using the tablets and contact your healthcare provider for alternative treatment options.
Contact InvaGen
We’ve drafted a message you can send InvaGen to request your refund or repair — edit it as you like.
Subject: Recall D-1212-2018 — InvaGen InvaGen Hello, I own a InvaGen that is covered by recall D-1212-2018 from InvaGen. 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-1212-2018 (September 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1212-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.