F.D.A. Recalls of Baby Formula

What? Baby Formula has been recalled? In fact, between 1982 and 1994 alone, there were 22 significant recalls of infant formula in the United States due to health and safety problems. Seven of these recalls were classified by the FDA as "Class I" or potentially life threatening.

And the problem doens't stop there. In the following we detail 9 recent recalls of formula. Recalls were made for all the well known companies, Nestle (Carnation), Abbott, Mead Johnson, Wyeth, Nutricia and more. Products were recalled for such things as contamination by Salmonella, Klebsiella Pneumoniae and bits of glass.

Some of the recalls were huge, the recall of jarred infant formala by Mead-Johnson contaminated with bits of glass covered more than 102,000 jars. Recalls noted below were made for such well known products as Alsoy, GoodStart, Isomil, Nutramigen and Soylac.

Hard to believe? Want to check out future recalls? You can get the information from where we got it: the US Food and Drug Administration (FDA). Their site for recalls is:

FDA Recall Enforcement Area

RECENT RECALLS OF INFANT FORMULA

June, 1993, Class III
PRODUCT: Mead Johnson Nutramigen brand Infant Formula, 20 calories/fluid ounce, in 3 ounce glass nursettes. Recall #F-480-3.
CODE: MME01 expires 1JUL93.
MANUFACTURER: Mead Johnson Nutritionals, Evansville, Indiana.
DISTRIBUTION: Nationwide, Canada.
QUANTITY: 102,048 bottles were distributed.
REASON: The product was contaminated with glass particles.

December, 1993, Class II
PRODUCT: Nursoy Soy Protein, iron fortified infant formula concentrate, in 13-ounce cans. Recall #F-113-4.
CODE: Two line code: AF28A/NOV94 and BG28A/NOV94.
MANUFACTURER: Wyeth-Ayerst Laboratories, Inc., Mason, Michigan.
DISTRIBUTION: Ohio, Michigan, Illinois, Pennsylvania, Wisconsin.
QUANTITY 10,250 cases (12 cans per case) were distributed.
REASON: Some cans are contaminated with Klebsiella pneumoniae and Pseudomonas aeruginosa which poses a mild to moderate hazard to health in the form of gastrointestinal stress to infants and new borns with developing microbial flora.

September, 1996, Class II
PRODUCT: Carnation Follow-up Infant Formula, ready to feed, in 32 fluid ounce cans. Recall #F-176-7.
CODE: Lot numbers: 6192EWFR617 and 6192EWFR618.
MANUFACTURER: Nestle Food Company, Nutritional Products Division, Eau Claire, Wisconsin.
DISTRIBUTION: Nationwide.
QUANTITY: 11,317 cases (6 cans per case) were distributed.
REASON: The product is adulterated because it may have been produced under insanitary conditions whereby it may have been rendered injurious to health. Furthermore, the product appears separated and has been linked with mild gastrointestinal illness.

July, 1993, Class I
PRODUCT: Soylac Powder, Infant Formula, in 14 ounce cans. Recall #F-492-3.
CODE : Recall Extended on June 22, 1993 to include all lots with partial code W5330. NO 94/W5310/923081 (Canadian) and NOV 94/W5330/923082 (US).
MANUFACTURER: Nutricia, Inc., Mt. Vernon, Ohio.
DISTRIBUTION: Nationwide, Canada.
QUANTITY: Unknown.
REASON: The product is contaminated with Salmonella.

September 1996 - Class I
PRODUCT: Alsoy Soy Formula, concentrated liquid infant formula, in 13 ounce cans. Recall #F-718-6.
CODE: 6150EWAC047 Note: Only the portion of the lot with incorrect lids is being recalled. These lids state "DO NOTADD WATER" and are written in English and French.
MANUFACTURER: Nestle Food Company, Nutritional Products Division, Eau Claire, Wisconsin.
DISTRIBUTION: Maryland, Michigan, New York, New Jersey, Pennsylvania, Virginia.
QUANTITY: 2,764 cases (12 cans per case) were distributed.
REASON: A portion of this lot of concentrated infant formula was manufactured with lids intended for ready-to-feed formula. The potential exists for a consumer to follow the lid directions (DO NOT ADD WATER) and not properly dilute the formula prior to feeding.

June, 1997 class III
PRODUCT: Isomil brand Soy Protein Infant Formula with Iron. Recall #F-414-7.
CODE: All lot numbers. Product expires in February 1998.
MANUFACTURER: Abbott Laboratories, The Netherlands.
DISTRIBUTION: Ohio.
QUANTITY: 104 cases (6 cans per case) were distributed.
REASON: The infant formula does not contain the labeled amount of inositol, a nutrient required under 21 CFR section 107.100.

September, 1993 Class III
PRODUCT: Infant formulas, special nutritional dietaryformulas, and dried dairy blend foods (93-658-050).
AGAINST Maple Island, Inc., a corporation, and Daniel W.O'Brien and Ronald D. Zirbel, individuals, Stillwater andWanamingo, Minnesota.
CHARGES: The defendants were charged with adulterating their products because they were manufactured, prepared, processed, packaged, and held for sale under insanitaryconditions whereby they may have become contaminated with filth or rendered injurious to health. Defendants were further charged with adulterating products manufactured attheir facilities due to the presence in those products and in the equipment that produced those products, of salmonella bacteria, a poisonous or deleterious substance,which may have rendered them injurious to health.
FILED August 17, 1993, Complaint for Injunction; August20, 1993, Consent Decree of Permanent Injunction; U.S.District Court for the District of Minnesota; Civil #4789; INJ1332.

October, 1994, Class II
PRODUCT: Carnation Good Start Infant Formula Concentrated Liquid in 13 fluid ounce cans. Recall #F-013-5.
CODE: Lot numbers: 4067EWGC447 (U.S.); 4062EWGC443 and 4067EWGC446 (Canada).
MANUFACTURER: Nestle Food Company, Eau Claire, Wisconsin.
DISTRIBUTION: Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah Washington state, Wisconsin, Canada.
QUANTITY: 16,878 cases were distributed; firm estimates none remains on the market.
REASON: A small number of cans were found to contain non-pathogenic spoilage organisms indicating the product has the remote possibility of being contaminated with other microorganisms.

Sept 22, 1993, Class II
PRODUCT: Isomil Soy Formula with Iron, (infant formula) Concentrated Liquid, in 13 fluid ounce cans. Recall #F-623-3.
CODE: DEC 94 I 77680 RC.
MANUFACTURER: Ross Laboratories, Columbus, Ohio.
DISTRIBUTION: New York.
QUANTITY: 324 cases (24 cans per case) were distributed by Wegmans.
REASON: Product is in cans with peeling can liners.