What are the Most Common Reasons for a Medicine Recall?

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  • Written By: Sara Schmidt
  • Edited By: Andrew Jones
  • Last Modified Date: 27 August 2019
  • Copyright Protected:
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A medicine recall is typically issued when a drug flaw is discovered. There may be a dosing error or cross-contamination, such as glass or other materials found in the medicine. A drug recall may also be issued when instructions are vague, or when a medicine has been found to be ineffective or dangerous.

Drug are often recalled when patients already taken a drug and experienced negative or even dangerous effects due to a dosing error or other mistake in production. A particular batch of medication may have been released to the public that was too strong, causing potential overdose. Alternatively, the dose could be too weak, resulting in the drug's ineffectiveness. Both an over-the-counter drug recall and a prescription drug recall can be issued.

Though some drugs may have been proven safe in clinical trials, they may ultimately remain unsafe for human use. Deaths or serious illnesses caused over time by prescription or over-the-counter drug use usually result in a medicine recall for that drug. People who have used these drugs and experienced ill health effects may be eligible for some type of compensation from the drug company.


When a medicine has been found to be ineffective and its use is integral to one's daily health, a health practitioner may call the patient to inform him or her of the recall. This may happen when the medication is used for heart problems, birth control, or other medicines that could result in illness or death if not taken properly, or if suddenly stopped. Clinics that provide medication, however, are more likely to make these calls than large pharmacies or hospitals.

Cross-contamination of a drug is often attributed to mechanical or human error. It may occur when equipment used to make the medication was not properly sterilized. Extraneous objects, such as fragments of glass or needles, can also be left in the medication by accident. Even less frequently, there have been cases in which someone has deliberately tampered with a drug for the purpose of causing harm to consumers. These types of medicine recall, however, are all typically quite rare.

Medicines are occasionally released with improper or confusing directions. The product packaging itself may be erroneous, or the packet of information inside the package could convey false or misleading information. When this occurs, a medicine recall may be issued to protect patients from overdosing or otherwise using the product improperly.

Sometimes drug recalls are issued when the drug itself is completely safe to use. When directions are unclear and could lead to incorrect dosing, a product recall may be issued to allow consumers to trade their products for something more user-friendly. This type of medicine recall has been instituted for some over-the-counter medicines, such as children's pain medication.



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Post 1

It seems like I see a commercial for the "bad drug" people advertising class action lawsuits every day. I think the first major drug recall I remember was the "phen-fen" mess when the "phen" drug was recalled. That infuriated my doctor, who said the recall was based on really bad science.

There have been other recalls since, for various reasons. I think when a medication is helpful, a patient should be offered the option to sign an indemnity waiver, saying he or she has been fully informed of the potential risks, chooses to continue taking the drug and will not sue the manufacturer. Some really beneficial drugs have been pulled from the market because of reports of bad side effects. But these drugs were helping many patients, and no effective substitutes have been approved.

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