Why Are Medications Recalled?

When you trust a medication to help you heal, the last thing you expect is for that same medication to cause harm. Yet medication recalls happen more often than many people realize. If you’ve been affected by a dangerous drug, understanding why these recalls occur and what steps to take can protect your health and your legal rights. 

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Why Are Medications Recalled? 

Medication recalls happen when drugs are removed from the market because they pose serious risks to the public’s health. There are various reasons for prescription recalls, but they’re necessary for patients who trusted these medications with their health. 

Understanding the specific reasons behind this form of medical negligence can help you recognize potential red flags and take appropriate action to protect your health. Here are the most common reasons for dangerous drug recalls:

Contamination

Contamination is one of the most common and serious reasons for medication recalls. When medications become contaminated during the manufacturing, storage, or distribution stage, they can pose severe health risks to patients who depend on them for treatment. 

Contamination can occur in several ways: 

• Bacterial or Fungal Contamination: This occurs when harmful microorganisms are in a medication, which can be especially dangerous in sterile products like injections or eye drops. 
• Heavy Metals or Chemical Impurities: Substances such as lead, arsenic, or unwanted chemicals can enter medications during manufacturing, posing serious health risks. 
• Foreign Particle Contamination: Tiny glass shards, plastic pieces, or other foreign materials can accidentally get into medications, potentially causing injury or illness. 
• Cross-Contamination: This happens when one medication becomes mixed with another, leading to patients receiving the wrong active ingredient and possibly harmful effects. 

Mislabeling 

Mislabeling a drug can have catastrophic consequences for patients who rely on accurate information to take their medications safely. When labels contain incorrect instructions, wrong drug names, or are missing critical warnings, patients face serious risks. 

Common mislabeling problems include: 

• Wrong Medication Name: A label that states the wrong drug can cause a patient to take a medication they were never prescribed, leading to potentially serious health consequences. 
• Incorrect Strength Information: If the dosage strength printed on the label is wrong, patients may take too much or too little of the medication, which can result in dangerous overdoses or ineffective treatment. 
• Missing or Confusing Dosing Instructions: When dosing instructions are unclear or missing entirely, patients may not know how often or how much to take, increasing the risk of misuse and harm. 
• Absent Allergy Warnings or Drug Interaction Information: Without proper warnings, patients may unknowingly take a medication that triggers an allergic reaction or interacts dangerously with other drugs they are using. 

When you are handed any prescription, you should carefully check the labels. If you notice any inconsistencies in your medication’s appearance, labeling, or packaging, contact your pharmacist immediately before taking a dose. 

Potency or Purity Problems 

When medications don’t contain the correct amount of active ingredient, patients may not receive the treatment they need, or they may receive dangerously high doses. Potency problems can make life-saving medications ineffective or create overdose situations that put patients at serious risk. 

Purity issues arise when medications contain impurities, degraded ingredients, or incorrect formulations. These problems often stem from manufacturing errors, inadequate quality control, or improper storage conditions that affect the medication’s integrity over time. 

Patients taking medications with potency or purity problems may experience treatment failure, unexpected side effects, or serious adverse reactions. For individuals managing chronic conditions like diabetes, heart disease, or mental health disorders, these medication failures can have life-threatening consequences. 

Manufacturing Defects 

Manufacturing defects include a wide range of problems that can occur during the production process. These product defects can affect how medications are delivered to the body, their stability over time, or their safety for patient use. 

Common manufacturing defects include: 

• Faulty Packaging: Packaging that does not properly seal can allow moisture or air to enter, which may degrade the medication and reduce its effectiveness. 
• Defective Delivery Systems: Problems with inhalers, injection devices, or other delivery mechanisms can prevent the medication from being administered correctly or safely. 
• Improper Tablet Compression: If tablets are not compressed correctly during manufacturing, it can alter how the drug is released and absorbed in the body. 
• Contamination from Unclean Equipment: Using manufacturing equipment that is not properly cleaned or maintained can introduce harmful contaminants into the medication. 

These defects can prevent medications from working as intended, cause harmful side effects, or create safety hazards for patients. Manufacturing defects often affect entire batches of medication, leading to widespread recalls that can impact thousands of patients. 

Who Can Recall Medications? 

The responsibility for medication recalls falls primarily on two key players: the drug manufacturers themselves and the Food and Drug Administration (FDA).  

Most recalls are voluntary actions taken by pharmaceutical companies when they discover problems with their products. These companies have a legal and ethical responsibility to monitor their medications continuously and remove dangerous products from the market when safety issues arise. 

Public announcements are made when a recall involves a serious hazard or wide distribution; if the company does not notify the public, the FDA may do so. Patients may also hear from their doctor, pharmacist, or the manufacturer. 

In rare cases, the FDA can issue a mandatory recall on medication orders when companies refuse to remove dangerous products from the market voluntarily. 

Medications that have lawsuits against them: 

• Weight Loss Drugs 
• Ozempic 
• Depo-Provera 
• Elmiron 
• Zantac 
• Zofran 
• Zoloft 

The FDA’s Recall Classifications 

The FDA classifies prescription medication recalls into three distinct categories based on the level of health risk they pose to patients: 

• Class I Recall: The most serious recall. The product could cause serious health problems or death if used. 
• Class II Recall: The second-most serious recall. The product might cause temporary or reversible health issues, and the chance of serious harm is low. 
• Class III Recall: The least minor recall. The product is unlikely to cause any health problems. 
• Market Withdrawal: The product has a minor issue that does not require FDA legal action. The company removes it from shelves or fixes the problem, such as in cases of tampering without manufacturing or distribution defects. 
• Medical Device Safety Alert: Issued when a medical device may pose a high risk of serious harm. In some cases, this is treated as a recall. 

What to Do If Your Medication Is Recalled 

Learning that your medication has been recalled can be frightening and overwhelming. However, taking the right steps quickly can protect your health and preserve your legal rights if you’ve been harmed. 

Here are some tips on how to handle medication recalls: 

• Stay Informed: Check the FDA website regularly for drug recall updates, sign up for email or text alerts from the FDA or your pharmacy, and pay attention to any recall notices or instructions provided by your pharmacy. Click here to find the right resource for you to stay informed about FDA drug recalls. 
• See if You’re Affected: Look for the lot number on your medication’s label and contact your pharmacy with that number to find out if your medication is part of the recall. 
• Talk to Your Healthcare Provider: Never stop taking your medication without medical guidance, and consult your doctor or pharmacist about safe alternatives or whether it is still safe to continue your current prescription. 
• Dispose of Medication Safely: Follow FDA disposal guidelines. Depending on the type of medication, this can mean numerous actions, including the National Prescription Drug Take Back Day, mailing the prescription, or disposing of it at home. Consult an expert before taking any of these steps. 
• Report Side Effects: If you notice any problems or side effects from a recalled medication, inform your healthcare provider or submit a report to the FDA’s Adverse Event Reporting System (FAERS). 
• Contact a Medication Error Lawyer: If you have been harmed because of taking a faulty prescription, you may be entitled to legal damages. Contact a medical malpractice attorney for legal guidance. 

Read Further: How Long Does a Medical Malpractice Lawsuit Take? 

How to Stay Informed About FDA Drug Recalls

• Sign up to receive FDA emails about recalls, market withdrawals, and other safety alerts. 
• Join the FDA Enforcement Report mailing list for updates on recalls the FDA is monitoring. 
• Click here to search for recent FDA recalls. 
• Sign up for weekly emails from the Enforcement Report page for a more thorough list of recalls. 

Have questions about recalls? Contact drug information pharmacists from the FDA. You can contact them by email at [email protected] or call them at 1-855-543-3784. 

Speak to a Dangerous Drug Lawyer Today 

If you’ve been harmed by a recalled medication, you don’t have to face this challenge alone. At DM Injury Law, we understand the devastating impact that dangerous drugs can have on your life and the lives of your loved ones. We’re here to fight for your rights and help you seek the justice and compensation you deserve. 

Speak to a medication error attorney today over a free consultation. Our attorneys and support staff of investigators, case managers, and medical records specialists will look over your medical records, FDA announcements, and other evidence that will help build a strong case. 

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