FILE PHOTO: A Johnson & Johnson Building Appears in Irvine, California, USA, January 24, 2017. REUTERS / Mike Blake
The recall is limited to a lot of Johnson's baby powder produced and delivered in the US in 2018, the company says.
The company's shares fell 2% to $ 133.01 in pre-market trading.
J&J also said that it has started an investigation and is working with health and regulatory authorities to determine the integrity of the tested sample as well as the validity of the test results.
The FDA test indicated the presence of a maximum of 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 result, if it was taken from a bottle with an intact seal or if the sample was prepared in a controlled environment.
It also admitted that it could not confirm whether the product was valid or counterfeit.
J&J is facing thousands of lawsuits related to products containing talc. The company has repeatedly stated that its talc products are safe, and that decades of studies have shown that they are asbestos-free and that they do not cause cancer.
Reporting by Tamara Mathias and Ankur Banerjee in Bengaluru; Editing by Sriraj Kalluvila and Saumyadeb Chakrabarty