Reasons for Drug Recalls

The Food and Drug Administration (FDA) is the agency responsible for ensuring that our medications are safe. If the FDA determines that there is a problem with a certain drug, it will request that the manufacturer recall the product. There are several reasons why the FDA will demand the recall of a drug:

  • It is a health hazard – Officials do not always realize the health risks associated with certain drugs before the drug reaches wide circulation. Fear of temporary or permanent damage to a user’s health will lead the FDA to issue a recall.
  • It is mislabeled or poorly packaged – There can be serious consequences if the drug in the package is not the same as that listed on the label. Sometimes the FDA will request a recall because of confusing dosing instructions or a problem with the dosing tool provided with the drug.
  • It is potentially contaminated – Either during production or during distribution, drugs can become contaminated with harmful or non-harmful substances.
  • It is poorly manufactured – If authorities consider a drug defective due to its quality, purity or potency, it could be recalled.

If the drug recall is for an over-the-counter medication, stop taking it immediately. If the drug is a prescription medication, contact your doctor immediately.

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