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Product recalls

General requirements

Are there any statutory criteria under which a product must be recalled or other corrective action be taken?

The requirements of a recall depend on the federal agency overseeing the defective product at issue:

  • The Food and Drug Administration has jurisdiction over cosmetics, foods, drugs, medical devices and tobacco products – 21 CFR Section 7.40 provides general guidance on recall procedures.
  • The Consumer Product Safety Commission oversees consumer products used in homes, schools and recreation (eg, coffee makers, toys and lawnmowers) – 15 USC Section 2064 provides general guidance on recall procedures.
  • The National Highway Traffic Safety Administration regulates motor vehicles – 49 CFR Section 573.6 provides general guidance on recall procedures.

Generally, a company must contact the appropriate federal agency immediately and report the defective product. Together, the company and agency formulate a plan for recall.


What rules and procedures govern notification of the product recall to government authorities and the public?

The notification process depends on the federal agency involved. Generally, the company and the federal agency will issue a press or news release to alert the public of the defective product. If the company can identify the specific consumers who own the defective product, a notification letter will be sent directly to those individuals. A website, toll-free telephone number or email address must be established to respond to questions.

Repairs, replacements and refunds

What rules and procedures govern repairs, replacements and refunds for defective products?

It depends on the federal agency, though it generally requires the same procedures as the recall.


What penalties apply for non-compliance with the legal provisions governing product recalls?

Depending on the federal agency, civil penalties of thousands or millions of dollars (according to the degree of the violation) and criminal penalties may apply.

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