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Product Recalls


A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.

A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination.


Class I: A dangerous or defective product that could cause serious health problems or death.

Class II: A product that might cause a temporary health problem or pose a slight threat of a serious nature.

Class III: A product that is unlikely to cause any adverse health reaction, but that violates the labelling or manufacturing laws.

Class I recalls are the most serious and involve situations where there is a reasonable probability that the use of or exposure to a violative product, will cause serious adverse health consequences or death.

Voluntary Vs Statutory Recall

Voluntary recall can be triggered by any incident that affects the quality, safety and efficacy of the batch or product in question.

Statutory recall can be triggered in response to the direction or mandate by the Drug Regulatory Authorities when the drug product or batch, is not of standard quality, or To recall the banned drugs. Statutory recall may even the Labeling or Promotional materials are considered to be in violation of law.


FDA Recall Alerts: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Pending recall classification in the United States

On June 15, 2017, as part of a larger effort to increase transparency, empower consumers, and enhance public health, the Enforcement Report began listing recalls pending classification, or “not yet classified” recalls, in addition to classified recalls, to alert the public sooner whenever a product has been recalled.

In these instances, the FDA has determined that a firm’s action meets the definition of a recall however the FDA has not completed its assessment of the hazard posed by the recalled product(s) yet – this is considered a pending classification. Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification (Class I, II or III) indicating the hazard posed by the recalled product(s). This initiative allows the FDA to post certain recalls to the Enforcement Report sooner since the Agency is no longer waiting for the hazard assessment to be completed.

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