11 million bottles of acetaminophen recalled

NEW YORK (CNNMoney.com) -- About 11 million bottles of store-brand acetaminophen caplets are being recalled by the manufacturer over concerns some may contain small metal fragments.

Perrigo Co., one of the largest domestic makers of store-brand, over-the-counter drug and nutrition products, said it had found trace amounts of metal in a small number of 500 milligram caplets.

Millions of bottles of the widely used generic pain reliever acetaminophen sold by Wal-Mart, CVS, Safeway and more than 100 other retailers have been recalled.

The company said that it was recalling 383 batches of the product after some were found to be contaminated.

The recall only involves generic versions of acetaminophen, not the Tylenol brand of the drug.

Perrigo (down $1.01 to $17.00, Charts) shares tumbled about 6 percent in afternoon trading on Nasdaq.

"We are taking this measure to maintain the highest possible product quality standards for our retail customers and their store-brand consumers," Perrigo executive vice president John Hendrickson said in a statement.

The FDA said the metal pieces found so far range in size from a microdot to a wire fragment 8 mm in length. It said that no illnesses or injuries have been reported, but ingesting the metal pieces could cause minor stomach discomfort, minor cuts to the mouth or throat and bleeding.

The agency said it believes the risk of the problem is very small, but it couldn't say how many states the contaminated medicine might have been shipped to.

Perrigo's customers include Wal-Mart (down $0.64 to $46.39, Charts), CVS (down $1.01 to $28.61, Charts), Longs Drug Stores, Kroger (up $0.06 to $22.25, Charts), Safeway, Dollar General and Save-a-Lot, the company said.

Both Wal-Mart and CVS said Thursday they already pulled the Perrigo-manufactured products off their shelves and would block the sale of these items at their registers as a precautionary measure.

Michigan-based Perrigo said it noticed a problem when the equipment making the tablets was wearing down sooner than expected. Its quality control system detected traces of metal pieces in a small number of the caplets, it said.

The company, which competes with Alpharma (up $0.12 to $22.26, Charts) and Chattem (down $0.31 to $45.35, Charts), is informing distributors and retailers of the problem and has said it's working with the FDA throughout this process. It advised customers to call 877 546-0454 with questions or comments.

It also said that any adverse reactions from using the product should be reported to the FDA by calling 800 FDA-1088 or faxing 800 FDA-0178 or by going on the MedWatch Web site at http://www.fda.gov/medwatch.

A list of the batch numbers of the acetaminophen can be found online, and the FDA advised consumers to look for the numbers on the labels of their bottles. The recall includes more than 380 batches of the product that could have been shipped to 129 chain stores. Expiration dates range from September 2006 to August 2009.

The list of batch numbers can be found at www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. A list of the potential stores can be found at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.

The FDA said this recall only involves 500 mg caplets and will not cause a shortage of the medicine.

--CNN's Christy Feig contributed to this report

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