FDA Alerts Public, Clinicians About Acetaminophen Recall

FDA officials have issued a public alert about a nationwide recall of 383 lots of 500-milligram acetaminophen caplets following the discovery of small metal fragments in some of the caplets. The voluntary recall, which is being conducted by Perrigo Company of Allegan, Mich., involves approximately 11 million bottles manufactured and distributed under various store brand labels.

According to a Nov. 9 FDA news release, no instances of illness or injuries related to this problem and no consumer complaints have been reported to the FDA or to Perrigo.

Consumers can determine if they are in possession of a recalled bottle by locating the batch number printed on the container label. Visit the FDA Web site for a list of batches included in the recall and for a list of the stores that carry brands potentially involved in this action.

Although the likelihood of serious injury resulting from use of the affected acetaminophen is thought to be minimal, minor stomach discomfort or cuts to the mouth or throat could result from swallowing the pills. Consumers are encouraged to consult their physicians if they suspect they've been harmed by using this product.

Clinicians should report any adverse reactions to the FDA's MedWatch program via the MedWatch Web site, by phone at (800) FDA-1088 or by fax at (800) FDA-0178.