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FDA Recall

An FDA recall happens when a product breaks FDA rules and could harm public health. Recalls can happen with food, drugs, medical devices, cosmetics, and other regulated products. These items might be contaminated, mislabeled, defective, or unsafe.

The FDA, or Food and Drug Administration, is a U.S. government agency. It protects public health by regulating goods. It ensures that products are safe, effective, and properly labeled before they reach the market.

Types of FDA Recalls

  • Class I Recall: The most serious type, for products that could cause severe health problems or death (e.g., contaminated medicine).
  • Class II Recall: For products that may cause temporary or moderate health issues (e.g., mislabeled food allergens).
  • Class III Recall: For products unlikely to cause harm but still violate FDA regulations (e.g., minor packaging defects).

How FDA Recalls Happen

  • Voluntary Recall: The company discovers the issue and recalls the product on its own.
  • FDA-Requested Recall: The FDA asks the company to recall the product due to health risks.
  • FDA-Mandated Recall: In rare cases, the FDA orders a recall when a company does not take action voluntarily.

When a recall is issued, the FDA keeps track of the process. They make sure the product is taken off the market and that any needed changes are made to keep consumers safe.

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