More than 11 million bottles of pain-relieving acetaminophen were recalled Thursday, Nov. 9, after some were contaminated with metal fragments.

The recall affects bottles containing 500-milligram caplets made by Perrigo Co., and sold at Wal-Mart, CVS, Safeway and more than 100 other retailers that offer the medicine under store labels. It does not affect the brand name Tylenol.

There were no immediate reports of injuries or illness.

On the agency's website, the U.S. Food and Drug Administration said swallowing the contaminated pills could lead to "minor" stomach discomfort or cuts to the mouth and throat. The risk for serious injury was remote, the regulatory agency added.

Numbers to call

The metal fragments range in size from "microdots" to wire one-third of an inch long. Based in Alelgan, Mich., Perrigo found metal in about 200 pills after passing 70 million caplets through a metal detector, FDA officials said.

Consumers who believe they have affected products should discontinue use immediately and call Perrigo, (877) 546-0454 for further instructions. People having adverse reactions from using the product should call the same number and the FDA's MedWatch Program, (800) FDA-1088, or visit the MedWatch website.

The FDA does not anticipate the recall will cause a shortage of acetaminophen, since only one strength - 500 mg caplets - is affected.

"Consumers may wish to take additional amounts of the lower strengths of acetaminophen tablets or caplets, which are not affected by this recall, to reach the 500 mg dose or access acetaminophen produced by alternate manufacturers," the FDA said, in a statement. "In all instances, FDA advises consumers to follow labeled instructions for maximum daily dosage."

Part of a $2 billion pain-reliever market, acetaminophen is better known by the brand name Tylenol, but is widely available in generic versions. Perrigo is one of the country's largest manufacturers of over-the-counter pain relievers, cough and cold medicines, antacids, laxatives and nutritional products, according to its website.

Source: U.S. Food and Drug Administration

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