Periscope News Group
More than 1,321 recalls were issued last year for human drug products that were defective or violated laws enforced by the U.S. Food and Drug Administration. It’s the highest figure in the past three years, a USA TODAY analysis of FDA data found.
Are your medications on the list of drugs removed from the market, relabeled, destroyed, or otherwise dealt with by the manufacturer since 2012? Search our database below to find out.
Almost 90% of 2022 drug recalls were for problems the FDA said could cause a temporary health issue and posed only a slight threat of a serious nature. An additional 10% of recalls were for products the FDA says are unlikely to cause any adverse health reaction but ran afoul of FDA labeling or manufacturing laws.
A total of 83 recalls last year were in the FDA's highest risk category, meaning they stemmed from drug problems the agency says "predictably could cause serious health problems or death."
For example, in November, sodium bicarbonate injections from Exela Pharma Sciences LLC were recalled because of complaints of vial breakage and glass flying when pressurized while preparing the product for administration. The month before, 22,400 octreotide acetate injections from Viatric Inc. were recalled because of the presence of glass particles in the syringe.
Most recalls happen because either a company discovers a problem, or the FDA raises concerns. The company recalls the product voluntarily. Only on very rare occasions does the FDA take legal action, typically against manufacturers that persist in marketing a defective product. Only 29 of the 14,732 recalls that were issued since 2012, when the data was first published, were mandated by the federal agency.
The recalling firm with the highest number of recalled products in the FDA's high-risk category is King Bio Inc. In 2018, King Bio officials initiated a voluntary recall of 465 products distributed nationwide in the United States, Canada, and Australia. All were recalled due to “possible microbial contamination” that could have potentially resulted in life-threatening infections for consumers.
Most of King Bio's recalled drugs were homeopathic products for children, including chicken pox, fever, flu, and colic relievers; children's appetite enhancers; and newborn tonics.
The company's news release at the time said King Bio didn't receive reports of injuries or illness but decided to recall the products "out of an abundance of caution" because the products tested positive for microbial contamination.
Aidapak Services LCC, had the largest number of drug recalls of any kind. In 2013, the company initiated recalls for 538 of its products due to a “labeling mixup,” according to FDA reports. Hundreds of Aidapak products distributed in Arizona, California, Oregon, and Washington were mislabeled.