What medicine is the FDA removing? A Guide to Recent Drug Recalls and Withdrawals

In the interest of public health, the FDA is taking action on several medications. A key question arises: What medicine is the FDA removing and why? The FDA regularly removes or recalls drugs from the market, from contamination to failed clinical trials.

Quick Summary

The FDA is actively addressing several medications, such as the proposed removal of oral phenylephrine due to ineffectiveness. Also the withdrawal of the cancer drug Pepaxto is due to safety concerns. Drug recalls have been issued for a variety of quality issues.

Key Points

• Oral Phenylephrine Removal Proposed: The FDA is proposing to remove oral phenylephrine, a common over-the-counter decongestant, due to a lack of proven effectiveness, not safety concerns.

• Pepaxto Approval Withdrawn: The cancer drug Pepaxto (melphalan flufenamide) had its approval officially withdrawn by the FDA in early 2024 after clinical trials failed to confirm its safety and efficacy.

• Numerous Recalls for Quality Issues: Many drugs were voluntarily recalled in 2024 and 2025 due to manufacturing defects, contamination (e.g., Zicam nasal swabs), or the presence of impurities.

• FDA Can Force Recalls: The FDA has the legal authority to compel a recall or seize products if a company fails to act.

• Impacts on Patients: Drug removals can interrupt patient treatment and cause health concerns, requiring consultation with a healthcare provider to find safe and effective alternatives.

• Drug Recalls Categorized by Severity: FDA recalls are classified into Class I (most severe), Class II, and Class III based on the potential health consequences associated with the defective product.

The U.S. Food and Drug Administration (FDA) plays a crucial role in safeguarding public health by ensuring the safety and effectiveness of drugs available to consumers. The agency takes various actions, including proposing removals, formal withdrawals, and overseeing recalls, when new information or issues arise regarding medications. Understanding these actions is vital for both healthcare professionals and the public.

The Proposed Removal of Oral Phenylephrine

A notable recent development is the FDA's proposal to remove oral phenylephrine from its list of approved over-the-counter (OTC) nasal decongestants. This ingredient is commonly found in many cold and allergy products.

Why Oral Phenylephrine May Be Removed

The proposed removal is based on evidence indicating that oral phenylephrine is ineffective as a nasal decongestant at the recommended doses. An FDA advisory committee concluded that studies have not demonstrated its efficacy when taken orally, primarily because it is poorly absorbed into the bloodstream. It is important to note that the nasal spray form of phenylephrine is considered effective and is not subject to this proposed action. The FDA initiated a public comment period on this matter.

The Withdrawal of Pepaxto (Melphalan Flufenamide)

In contrast to the proposed removal of an OTC ingredient, the FDA formally withdrew its approval for the prescription cancer drug Pepaxto (melphalan flufenamide) in February 2024.

Reasons for Pepaxto's Withdrawal

Pepaxto was initially approved under the accelerated approval pathway for treating multiple myeloma. However, a required post-market clinical trial (the OCEAN trial) showed that patients receiving Pepaxto had a higher risk of death compared to those on a different treatment regimen. This trial did not confirm the drug's clinical benefit and raised significant safety concerns, leading the FDA to withdraw its approval.

Other Recent Drug Recalls

Beyond these specific cases, numerous drug recalls occur regularly due to a variety of quality control issues.

Common Reasons for Recalls:

• Contamination: Recalls have been issued for products found to have microbial contamination, such as Zicam Cold Remedy Nasal Swabs and various DermaRite products.
• Potency Issues and Impurities: Some recalls stem from drugs failing to meet potency specifications or containing unacceptable levels of impurities. Examples include specific lots of Carvedilol and Rizatriptan.
• Mislabeling: Errors in labeling, where a product is incorrectly identified, can also lead to recalls.

Understanding FDA Actions: Withdrawal vs. Recall

It's important to distinguish between different types of FDA actions regarding medications.

Factor	Proposed Removal	Formal Withdrawal	Voluntary Recall
Reason	Lack of demonstrated effectiveness.	Failure to prove safety or effectiveness post-approval.	Manufacturing defects, contamination, mislabeling, or quality issues.
Initiation	FDA decision, followed by public comment.	FDA final decision after reviewing evidence.	Initiated by the manufacturer, often at FDA's request.
Timeline	Lengthy process with transition period.	Can be effective immediately.	Can be rapid, depending on severity.
Scope	Targets the entire ingredient in all products for that indication.	Revokes approval for the specific drug.	Affects specific batches or lots.

Impact on Patients and Industry

Drug removals and recalls can significantly impact patients, potentially disrupting treatment or causing health concerns. Patients affected by a removal or recall should consult their healthcare provider for alternative treatments. The pharmaceutical industry faces financial losses and reputational damage from recalls, highlighting the importance of rigorous quality control.

Conclusion

The FDA's actions, from proposing the removal of oral phenylephrine to withdrawing Pepaxto, are essential for protecting public health. These regulatory measures, along with manufacturer recalls, ensure the safety and efficacy of medications. Consumers should stay informed through official FDA sources and consult healthcare professionals regarding any concerns about their medications.

For additional information on drug safety, visit the official FDA website.

Frequently Asked Questions

Why did the FDA propose to remove oral phenylephrine?

The FDA proposed removing oral phenylephrine because an advisory panel found it to be ineffective as an oral nasal decongestant after an extensive review of the available scientific data.

Is Pepaxto still on the market?

No, the FDA formally withdrew its approval for the cancer drug Pepaxto (melphalan flufenamide) in February 2024. The drug is no longer marketed in the U.S. because later studies showed it was not safe or effective.

What should I do if my medication is recalled?

You should stop using the recalled product immediately and contact your healthcare provider or pharmacist. They can provide guidance, discuss safe alternative treatments, and explain how to dispose of the recalled medication.

Does a recall mean a medication is unsafe?

A recall is issued when a product is defective or potentially harmful. The risk level is categorized, with Class I being the most severe, indicating a reasonable probability of serious adverse health consequences or death.

How can I find out about drug recalls?

The FDA website provides up-to-date information on drug recalls and safety communications. You can also sign up for alerts or ask your pharmacist or doctor.

What are the alternatives to oral phenylephrine?

Effective alternatives for nasal congestion include consulting a pharmacist for behind-the-counter pseudoephedrine or using a nasal spray decongestant containing oxymetazoline.

Can the FDA force a drug recall?

While the FDA typically requests a manufacturer to voluntarily recall a drug, it has the legal authority to force a recall if the company refuses, using court orders or seizure actions.

What types of quality issues lead to recalls?

Recalls can be caused by a wide range of quality issues, including microbial contamination, incorrect labeling, failed potency tests, impurities (like nitrosamines), and defective packaging.