Abbott Laboratories is voluntarily recalling up to 5 million containers of its popular powdered Similac infant formula after finding evidence that beetles had possibly contaminated it. The U.S. Food and Drug Administration cautioned that tiny insect parts could irritate babies' delicate digestive tracts, and might make them refuse to eat.
Abbott, which initiated the recall after detecting "the remote possibility of the presence of a small common beetle," believes the recalled lots "pose no serious health concern," spokeswoman Raquel Powers said in an interview Thursday. The company, headquartered in the Chicago suburb of Abbott Park, said the recall affects all rectangular plastic tubs of powdered Similac and some 8-ounce, 12.4-ounce and 12.9-ounce cans manufactured in one area of a plant in Sturgis, Mich., and distributed in the United States, Guam, Puerto Rico and the Caribbean. Abbott does business in more than 130 countries.
The warehouse beetle, Trogoderma variabile, is an oval-shaped insect, about one-eighth-inch long, and is commonly found in dried grains and other foods in office buildings, supermarkets, museums and houses. The adult form of the bug can fly.
The FDA determined that "while the formula poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae could experience symptoms of gastrointestinal discomfort" and refuse to eat. Parents should consult a doctor if symptoms persist more than a few days, the agency said.
After internal quality systems detected the presence of insect parts, "we tested the product and ... 99.8 percent of the product from the same lots tested negative," Powers said. On Thursday, Abbott continued to compile a list of affected lots. Cans bearing lot numbers with the following combinations -- T3, RE, 9V, NT -- were unaffected, as were all liquid Similac products, she said.
Containers included in the recall should be returned to the company at no cost to consumers. They can call the company's consumer hotline at (800) 986-8850 or go to www.similac.com/recall for further information.
Abbott, which manufactures nutritional products, diagnostic tests, medical devices and therapies for pain and cancer, has voluntarily recalled other Similac products in the last five years:
In February 2005, it recalled Similac Advance with Iron Formula Powder in 12.9-ounce cans because of black polyvinyl chloride plastic particles detected in some cans. The plastic contamination in containers distributed in 2004 was attributed to a manufacturing problem. No serious health or safety reports were attributed to the plastic.
In September 2006, it recalled 32-ounce plastic bottles of Similac Alimentum Advance ready-to-eat liquid formula, two lots of Similac Advance with Iron ready-to-eat infant formula and one lot of Similac Advance Hospital Discharge Kits, because consumers complained the formula was unusually dark in color. The company said bottles in affected lots might not contain as much vitamin C as indicated on the label and that "the problem is due to an isolated bottle defect" that was corrected by the third-party bottle supplier. The affected bottles were missing a special plastic layer designed to protect the formula from exposure to oxygen, which can reduce vitamin C content. No serious medical complaints were reported.
In May 2007, it recalled three lots of 2-ounce bottles of Similac Special Care Ready-to-Feed Premature Infant Formula with Iron, because they didn't contain as much iron as indicated on their labels. The company and the FDA said preemies fed the formula for more than a month after discharge "could have an increased risk of developing anemia due to insufficient iron intake," but no serious medical complaints were reported.