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Am I Eligible to File a Medical Malpractice Lawsuit After a Drug Recall?

Posted By Legal Team | March 3 2026 | Medical Malpractice

Safe, effective medications are a key aspect of healthcare, saving lives, extending lifespans, and improving the quality of life for millions of people daily. But medications are also powerful products with the potential for great harm when they are defective or include a dangerous ingredient.

It’s frightening to learn that a medication that’s been prescribed to you has been recalled, but can you file a medical malpractice lawsuit after a recall is issued on a medication you’ve taken?

A Chicago medical malpractice lawyer can evaluate the merits of your unique case.

When are Drugs Recalled?

A medication may be recalled voluntarily by the manufacturer or by the Food and Drug Administration (FDA) when it’s found to cause harm. Drug recalls occur to prevent the public from preventable harm from a dangerous medication. During a recall initiated voluntarily by the drug manufacturer or at the FDA’s request, the FDA conducts a Health Hazard Evaluation and then approves and monitors the manufacturer’s recall strategy. Recalls range from Class III recalls with little harm to patients to Class I recalls for dangerous drugs that cause serious or life-threatening effects.

When Is a Patient Able to File a Medical Malpractice Lawsuit for a Drug Recall?

Learning that a medication you’ve taken in good faith has been recalled is not typically enough to justify a medical malpractice lawsuit. To be eligible for a lawsuit, you must have evidence demonstrating the following:

  • That the medication caused you serious injury or a worsened medical outcome
  • That you suffered economic and non-economic damages from the injury, such as additional medical expenses, lost earnings, and pain and suffering

If you took a medication that caused you to suffer an injury and the manufacturer issued a recall for the medication, you may be eligible for a medical malpractice lawsuit or a defective product claim.

When is a Dangerous Drug Case a Medical Malpractice Lawsuit or a Defective Product Claim?

Depending on the circumstances of your case, you could have one or both of the following options for recovering compensation for your economic losses and pain and suffering after taking a dangerous medication and experiencing harm:

  • You could file a medical malpractice lawsuit against the doctor who prescribed the medication if they were aware of the dangers of the drug and failed to obtain your informed consent, or if they knowingly prescribed a recalled medication, or
  • You could file a defective product claim against the manufacturer of the medication

Proving a doctor’s medical malpractice requires evidence of their negligence and a breach of their duty of care. The evidence must demonstrate that the doctor failed to uphold their legal duty to provide treatment to you at the level of care accepted as standard by the medical community, and that their breach of duty caused you an injury with damages.

Contrarily, you do not have to prove negligence in a product liability lawsuit against a manufacturer due to the strict liability doctrine.

What Is Strict Liability for Manufacturers?

When filing a claim against a manufacturer for a defective product—including a dangerous drug—the injury victim does not have to prove negligence or malpractice. Instead, the evidence must show that the medication has a design flaw, a manufacturing error, or a marketing problem. Then, you must show that you suffered economic and non-economic losses from the medication, such as medical costs and lost earnings.

A Chicago medical malpractice attorney pursues all available avenues for recovering compensation for your damages after a dangerous drug causes you harm.

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