Millions of Bottles of Generic 500-mg Acetaminophen Recalled

ROCKVILLE, Md., Nov. 9 -- The FDA alerted the public today that some 11 million bottles of generic acetaminophen have been recalled by the Perrigo Company of Allegan, Mich., because of metal-fragment contamination in a small number of caplets.

The agency said that all caplets were in 500-mg strength and that the bottles had varying quantities of caplets. The 383 recalled lots were distributed to scores of retail outlets, including such giants as Wal-Mart and CVS that market the generic acetaminophen as store brands.

"There have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo," the agency said.

"Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote. 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 agency posted on its Web site a list of stores that carry store-brands potentially affected by the recall at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.

The agency also posted the list of recalled batches at www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html.

It added that Perrigo informed FDA of this problem after discovering through its regulatory quality control procedures that its tableting equipment was wearing down prematurely.

Perrigo reported to the FDA that 70 million caplets were passed through a metal detector; resulting in the discovery of approximately 200 caplets containing metal fragments ranging in size from "microdots" to portions of wire 8 mm in length, the agency said.