Johnson & Johnson is under investigation by the U.S Justice Department over its marketing practices for hip-replacement products it recalled in 2010.
Johnson & Johnson recalled hip replacements implanted in about 93,000 people because an excessive number needed a second hip-replacement procedure, resulting in millions of dollars in medical and litigation costs.
However, marketing divisions within Johnson & Johnson received an informal request from the government in August last year for the production materials on the ASR XL Hip Device.
Following this initial request, the U.S. attorney's office for the District of Massachusetts and the civil division of the Justice Department then asked for additional information.
Johnson & Jonson said in its annual report, filed on Friday: "The government is investigating whether any person or entity submitted or caused to be submitted false claims or false statements affecting federal health care programs in connection with the marketing and use of the ASR XL Hip device."