Why was bupropion taken off the market?

October 9, 2025 •

3 min read

In 2012, a specific generic version of bupropion, Budeprion XL 300mg, was voluntarily withdrawn from the market by its manufacturers, Teva and Impax, after an FDA study confirmed it was not therapeutically equivalent to the brand-name drug. This action led many patients to question why was bupropion taken off the market.

Quick Summary

A generic form of the antidepressant bupropion, Budeprion XL 300mg, was removed from the market after failing to demonstrate therapeutic equivalence to the brand name, Wellbutrin XL 300mg. Patient complaints regarding reduced efficacy and increased side effects triggered an FDA investigation, which ultimately found the generic's dissolution rate was not comparable to the original.

Key Points

Generic Version Recalled: A specific generic formulation, Budeprion XL 300mg, was taken off the market, not all bupropion products.
Reason for Recall: The recall was due to a failure to demonstrate therapeutic equivalence to the brand-name Wellbutrin XL 300mg, not a safety issue with bupropion itself.
Bioequivalence Failure: FDA testing found that Budeprion XL 300mg released its active ingredient at a different, faster rate than the brand-name version, potentially affecting efficacy.
Patient-Driven Action: Widespread patient complaints about reduced efficacy and increased side effects played a key role in prompting the FDA to re-investigate.
Market Impact: The incident led to stricter FDA scrutiny of other generic bupropion 300mg products and highlighted the need for better monitoring of complex generic drug formulations.
Bupropion Still Available: Bupropion (Wellbutrin) is still widely available in brand-name and other generic forms that have met bioequivalence standards.

The question, "Why was bupropion taken off the market?" is often based on a misunderstanding. It wasn't the entire drug that was removed, but rather a specific generic formulation, Budeprion XL 300mg, that was recalled due to issues with its bioequivalence to the brand-name drug, Wellbutrin XL 300mg. This incident, which became prominent in 2012, highlighted the complexities of generic drug formulations and the importance of post-market surveillance.

The Budeprion XL 300mg recall: A timeline

December 2006: Approval and initial reports

Following the patent expiration for Wellbutrin XL, the FDA approved several generic versions of bupropion extended-release, including Budeprion XL 300mg from Impax Laboratories and Teva Pharmaceuticals. Soon after its release, patients switching from Wellbutrin XL to Budeprion XL reported decreased effectiveness and increased side effects such as headaches and anxiety.

2007–2012: Advocacy and investigation

The FDA initially maintained the generic's therapeutic equivalence, as its approval for the 300mg dose was based on data from the 150mg dose to reduce seizure risk during testing. However, an independent lab found that Budeprion XL released bupropion faster in the initial hours compared to Wellbutrin XL. Consumer advocates continued to raise concerns based on patient reports and test results, urging the FDA to re-evaluate.

October 2012: FDA confirms bioequivalence failure

Under pressure, the FDA conducted its own study comparing Budeprion XL 300mg and Wellbutrin XL. The results confirmed that the generic did not release bupropion into the bloodstream at the same rate and extent as the brand name. Consequently, the FDA changed the generic's therapeutic equivalence rating from AB to BX, indicating insufficient data to confirm equivalence.

The aftermath: Withdrawal and new standards

Teva and Impax voluntarily ceased manufacturing and shipping Budeprion XL 300mg after the FDA's findings. While not a life-threatening recall, the FDA requested other generic bupropion XL 300mg manufacturers to conduct new studies with stricter protocols. This incident led to increased caution for drugs with narrow therapeutic windows, where small variations in release can significantly impact clinical outcomes.

Comparison: Brand vs. Recalled Generic


Feature	Wellbutrin XL 300mg (Brand)	Budeprion XL 300mg (Recalled Generic)
Manufacturer	GlaxoSmithKline (at recall)	Impax Laboratories / Teva
Active Ingredient Release	Slow, consistent	Faster initial release
Therapeutic Equivalence	Original standard	Failed study in 2012
Patient Feedback	Effective, well-tolerated	Complaints of reduced efficacy/increased side effects
FDA Rating	N/A	Changed to BX
Current Status	Available and approved	Withdrawn since 2012

Why the discrepancy mattered

The difference in release rate meant patients on the generic received a different drug exposure. For an extended-release drug meant to maintain steady levels, a faster initial release could cause a temporary spike and side effects, while a later decline could reduce effectiveness. Patient experiences were crucial in exposing this issue, as a loss of efficacy could significantly impact those with major depressive disorder.

Subsequent bupropion recalls and withdrawals

The Budeprion XL 300mg issue was a significant event, but there have been other smaller bupropion-related recalls since 2012, typically due to manufacturing or quality control problems, not fundamental therapeutic failure.

Examples of subsequent issues include:

Sun Pharmaceutical: Recalled over 30,000 bottles in 2019 due to dissolution problems.
American Health Packaging: Initiated a recall in 2024 for bupropion XL 150mg lots dissolving too quickly.
Zyban Discontinuation: The extended-release version of Zyban was voluntarily discontinued for business reasons, not safety or effectiveness concerns.

Conclusion: A lesson in generic oversight

The recall of Budeprion XL 300mg, which caused many to ask why was bupropion taken off the market, highlights the need for ongoing monitoring of generic drugs. While generics are generally reliable, the Budeprion incident showed that issues can arise, especially with complex formulations. Patient reports were key in prompting the FDA to re-evaluate and ultimately remove the product. Today, many safe and effective generic bupropion products are available, but this event underscores the importance of quality assurance and the value of patient feedback.

For more information on FDA drug recalls, visit the FDA's official website.

Frequently Asked Questions

Yes, bupropion is still widely available. The withdrawal in 2012 only affected a specific generic formulation, Budeprion XL 300mg, not all bupropion products.

Bioequivalence means that a generic drug delivers the same amount of active ingredient into the bloodstream at the same rate and extent as its brand-name counterpart, resulting in the same therapeutic effect.

An FDA study found that the Budeprion XL 300mg tablets released the active ingredient, bupropion, into the bloodstream faster than the brand-name Wellbutrin XL 300mg, causing it to fail the test.

Many patients reported a loss of effectiveness and an increase in side effects after switching to Budeprion XL 300mg. The FDA advised patients to consult their healthcare professional to switch to a therapeutically equivalent product.

While generic drugs are generally safe and effective, the Budeprion XL 300mg incident demonstrated that failures can occur, particularly with complex extended-release formulations. The FDA has since implemented stricter guidelines for certain generics.

Yes, other, less severe bupropion recalls have occurred for specific lots or manufacturers due to manufacturing issues like dissolution problems or contamination, but not for the same fundamental bioequivalence failure as Budeprion XL 300mg.

No, the extended-release Zyban product was discontinued by the manufacturer for business reasons unrelated to safety or effectiveness, according to FDA records.