Johnson & Johnson said on Friday it would recall a single lot of its baby powder in the United States after the Food and Drug Administration found trace amounts of asbestos in samples taken from a bottle purchased online.
The recall is limited to one lot of Johnson's Baby Powder produced and shipped in the United States in 2018, the company said.
The company's shares fell 2% to $133.01 in premarket trade.
J&J also said it has started an investigation and is working with health regulators to determine the integrity of the tested sample as well as the validity of test results.
The FDA test indicated the presence of no greater than 0.00002% of chrysotile asbestos in the tested sample, the company said.
The company's consumer unit said it was too early to confirm whether cross-contamination of the sample had caused a false positive, whether it was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment.
It also added it could not confirm whether the product was authentic or counterfeit.
J&J faces thousands of lawsuits related to products containing talc. The company has repeatedly said that its talc products are safe, and that decades of studies have shown them to be asbestos-free and that they do not cause cancer.