The FDA has been testing dozens of products for asbestos, a known carcinogen amid rising concerns among the public. It said there was no indication that the product was counterfeit or had been tainted during testing.
The FDA “stands by the quality of its testing and results”, it said.
It is not aware of any adverse events relating to exposure to the lot of affected products, it added.
It urged customers with products from lot #22318RB to contact Johnson & Johnson for a refund.
Shares in Johnson & Johnson fell more than 3% in morning trade.
Legal fight
The recall is the latest bad news for Johnson & Johnson, which is facing billions of dollars in legal claims over other products, including opioids and vaginal mesh implants.
A jury this month awarded $8bn to a man over claims he was not warned that an anti-psychotic drug could lead to breast growth.
As of February, the firm faced more than 13,000 lawsuits over contamination of its talc-based products, including baby powder, with cancer-causing asbestos.
