Friday's recall involves about 574,000 bottles of the grape-flavored liquid Tylenol for infants younger than 2 years old. Following earlier recalls, J&J had just returned to the market with the infant Tylenol in November, but now will be out of the market for an indefinite time.
The problems involves a new bottle design, which was intended to prevent accidental ingestion and ensure accurate dosing. But when parents inserted a syringe into the bottle, some accidentally pushed a protective cover inside. To date, J&J has received 17 complaints, company spokeswoman Bonnie Jacobs said.
No serious side effects from the infant Tylenol have been reported, and the risk of such problems are remote, J&J said.
The recall is from stores and wholesalers; consumers can still use the product provided that the protective cover at the top of the bottle remains in place, J&J said.
The recall does not affect Tylenol for children 2 years and older, for which J&J also introduced a new but different design.
The company had said last summer that it was planning to return its products to the markets with the improved designs.
J&J spokeswoman Jacobs said the company did not have a specific date for when it would return to the market with infant Tylenol.
We are looking for various alternatives for the redesign, Jacobs said. Once we have reviewed those options, we will set a timeline for the product to return.
The product was manufactured to specifications, so the company is investigating why it was not performing as expected, Jacobs said.
Jacobs said the company would only make note of a financial impact from the recall when it reports quarterly results, but that infant Tylenol was a relatively modest portion of overall sales.
The recall is the latest in a long series for J&J, including not only popular consumer medicine brands such as Tylenol, but also artificial hips and contact lenses.
The infant Tylenol product was manufactured at a plant in Latina, Italy. Last March, U.S. health authorities took over supervision of three other J&J manufacturing plants after the flood of recalls.
Shares of J&J were up 1 cent at $64.93 in morning trading.