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| - A Facebook post claims that the US Food and Drug Administration (FDA) has recalled 12,787 drugs and that “1,270 drugs every year that were formerly approved get recalled because they were subsequently deemed unsuitable. These drugs were pre tested for between 2-10 years.”
While it’s true that the FDA has recalled just under 1,000 drugs so far this year, these weren’t all because of the safety of the drug in general. Many were due to problems with labelling, the appearance and manufacturing of individual batches of a certain drug, or were drugs that were being distributed illegally.
The post claims that the numbers come from an FDA source. Full Fact couldn’t find these exact numbers on the FDA dashboard, but they were featured on a personal injury lawyer’s website, which also cites the FDA and says the figures were “since 2012”.
The Facebook post also claims that there have been 12,787 drug recalls by the FDA. The FDA dashboard states that since 2012 there have been over 13,000 drug recalls.
The FDA is the US body responsible for ensuring the safety, efficacy and security of human and veterinary drugs, products and devices in the US. It also has additional roles in the safety of food supply, cosmetics and products that emit radiation and in regulating tobacco products.
The FDA told Full Fact: “A drug recall may be initiated when a product, its labeling and/or marketing violate the laws administered by the FDA. A recall is generally a voluntary action taken by a company to remove a defective drug product from the market and may be conducted on a company’s own initiative or by FDA request.”
It added that the FDA also recalls over-the-counter, prescription and unapproved products that have been distributed illegally.
The FDA told us on 8 December that to date in 2021, there were 979 recalled products.
When Full Fact looked into this further from the FDA’s Enforcement Report, there were 996 search results returned from January to December 2021.
However, there were a very wide range of reasons for the recalls. Reasons included, for example, incorrect labelling, contaminated batches, and crystalized or discoloured items. The most common reason for recall, accounting for more than 300 recalls, was something called a ‘CGMP deviation’. This is when the manufacturing, processing or packaging of a drug doesn’t meet the current good manufacturing practice regulations that ensure the product is safe to use, or has the ingredients and strength that it claims to.
Some of the recalls we saw in that total 996 included things like hand sanitiser, which obviously isn’t a drug or medication. We asked the FDA what types of products the recall figure included, but it did not clarify.
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