Perrigo Co. is recalling 11 million bottles of over-the-counter, store-brand acetaminophen caplets after traces of metal were found in some of the products, federal health officials said on Thursday.
Various size bottles of 500-milligram caplets were distributed to stores such as Wal-Mart, Safeway, CVS and Food Lion.
Perrigo and the U.S. Food and Drug Administration said no injuries or illness had been linked to the products.
Perrigo shares fell nearly 4 percent to $17.32 in morning trade on Nasdaq.
“Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote,” the agency said in a statement.
“However, if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat,” the FDA said.
Consumers should stop using the recalled caplets and consult a doctor if they think they have been harmed, the agency added.
Perrigo discovered the problem by passing the pills through a metal detector during quality-control checks, the FDA said
“The frequency of occurrence is very low,” said John Hendrickson, executive vice president and general manager of Perrigo Consumer Healthcare.
The Allegan, Michigan, company — the world’s largest manufacturer of store-brand pharmaceutical and nutritional products — said the total cost of the recall is expected to be $2.9 million.
Perrigo said its recently reported fiscal first-quarter results will now include an after-tax charge of $667,000, or 1 cent a share, related to the recall, reducing its quarterly earnings to 18 cents a share. The company also reaffirmed its full-year earnings outlook.
A list of stores that carry brands potentially affected by the recall can be found at http://www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.
The FDA said consumers can determine which bottles are included in the recall by checking batch numbers at http://www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html.