Frequently Asked Questions about Vaccine Recalls

Vaccines go through years of testing before and after they are approved for use. Sometimes a vaccine or a particular lot (batch) of vaccine may be withdrawn or recalled from doctor's offices, clinics, hospitals, and other places permitted to administer vaccines.

Many types of products, including cars, toys, and food products, are sometimes recalled temporarily or withdrawn permanently from the market because they don't work properly or could pose a safety hazard. Similarly, vaccines or vaccine lots can also be withdrawn or recalled.

How is a vaccine or a batch recalled?

Vaccine recalls or withdrawals are almost always voluntary by the manufacturer. Only in rare cases will the Food and Drug Administration (FDA) request a recall. But in every case, FDA's role is to oversee a manufacturer's strategy and assess the adequacy of the recall.[1]

Why would a vaccine or batch of vaccine be withdrawn or recalled?

There have been only a few vaccine recalls or withdrawals, most due to concerns about the vaccine's effectiveness, not its safety. When the strength of a vaccine lot has been recalled, those vaccines may not produce an immune response that is strong enough to protect against disease. Although those vaccines may not be effective, they are still safe. Vaccines are tested carefully and monitored continuously before and after they are licensed for use. If a vaccine lot is found to be unsafe, the FDA recalls it immediately.

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How do I know if a vaccine lot is recalled?

Your doctor should notify you if a vaccine given to you or your child is recalled. When a recalled product has been widely distributed, the news media often reports on the recall. Not all recalls are announced in the media, but all recalls are listed in FDA's weekly Enforcement Reports. See a list of vaccines that have been recalled in the past few years.

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What do I do if a vaccine lot is recalled?

Most vaccine recalls are due to low vaccine potency or strength. When the strength of a vaccine lot is lower than it should be, vaccines from the lot might not produce an immune response that is strong enough to protect against disease. Therefore, the people who were vaccinated with a recalled vaccine may need to be vaccinated again to ensure they are protected against the disease.

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What is being done to monitor the safety of vaccines?

CDC, FDA, the National Institutes of Health, and other federal agencies monitor vaccine safety and investigate any possible problems with the safety of vaccines. The Vaccine Adverse Event Reporting System (VAERS) accepts reports from the public about possible problems following vaccination. The FDA reviews reports weekly and closely monitors reporting trends for individual vaccine lots.

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Reference

FDA 101: Product Recalls