Recalls of Infant Feeding Products

Recalls of Infant Feeding Products

Recall
Class Date
Product Problem

Firm initiated Recall 2001 Carnation Follow-Up formula, 32 ounce liquid ready-to-feed;
120 cans (Nestle) Excessive magnesium content in one batch; long term use could cause adverse health effects such as low blood pressure and irregular heart beat.

The Product was distributed only to Wal*Mart stores in 19 cities in Texas.

Firm initiated
allergy alert
2001 LactoFree and Enfamil AR sample packs. The LactoFree pack has two 3oz ready-to-use Nursette bottles and two Easy One single serving powder packets. The Enfamil AR sample contains three 3oz ready-to-use Nursette bottles and a single hole nipple
(Mead Johnson)
Ingredients are not listed on the back of the boxes.These sample packs were distributed to physicians nationwide to give to their patients. Infants allergic to milk protein run the risk of a serious or life threatening allergic reaction if they consume these products

Firm Initiated
Recall 2001 LactoFree sample packs containing two 3 ounce ready-to-use nursette bottles and two Easy One single serving powder packets
(Mead Johnson) Packages failed to list the ingredients on the back of the box. Infants allergic to milk protein are at risk of life threatening allergic reaction if they consume the product. The sample packs were shipped to 30 stores in nine states, Colorado, Iowa, Kansas, Louisiana, Minnesota, Missouri, Oklahoma, Texas, & Tennessee.

Firm Initiated
Recall 2001 Nutramigen powder (3.7 million 16 oz cans) and Nutramigen ready to feed (930,000 32oz cans) (Mead Johnson)
The cans have incorrect preparation instructions in Spanish that could lead to seizures, an irregular heartbeat, or death if the altered formula is consumed for several days. Infants already ill or who live in hot climates are at greater risk for potentially fatal complications. The formula was distributed nationwide as well as in Guam, the Dominican Republic, and Puerto Rico. The offending product was permitted to remain on the shelves in stores, with correct preparation instructions in Spanish posted as tear off sheets that the consumer was responsible for noticing

III 2000
Firm-initiated recall Repackaged infant formula: Isomil powder and concentrate; Similac with iron, low iron powder and concentrate; Neosure powder; Enfamil low iron and with iron powder, Enfamil Lacto-free powder; Prosobee soy powder;
Nutramigen powder
2000-3000 cases
The infant formulas were repackaged in cardboard trays/boxes which are misbranded. All lots of cardboard cases and trays that were repackaged, labeled, and distributed by Unity Wholesale Grocery since April 25, 2000

III 2000 Carnation Good Start, Alsoy, and Follow-up in 13oz concentrate cans (2.5 million cans)
(Nestle)
Processing may not have reached high enough temperatures to ensure sterility

II 1999 Isomil ready to feed soy formula in 32 oz metal cans; 17,821 cases (106,926 cans)
(Ross Laboratories) Product was held in cans with a low level of can lid defects allowing for post-processing contamination

Manufacturer’s Voluntary Recall ProSobee soy formula; 8oz, ready to use cans sold in 4-pack cartons; case potential to (Mead Johnson) Cans in the batch mislabeled ProSobee when they
Voluntary Recall actually contained vanilla Sustacal, an adult 7000nutrition supplement. Consuming Sustacal has the cause severe medical problems in infants, especially if they are ill, highly sensitive to milk proteins or have galactosemia. Because it has a higher caloric density and renal solute load as compared to ProSobee, Sustacal also has the potential to cause dehydration in healthy infants.

I 1999 Heinz 3 Broccoli, Carrots and Cheese Junior Baby Food; 6oz glass jars; 5,269 cases (24 jars/ case) (Heinz USA)

Product contaminated with pieces of hard plastic

III 1999 Carnation Follow-Up formula; 32 oz cans; 12,651 cases (6 cans/ case) (Nestle USA)

Product has a lumpy, curdled appearance

II 1998 Beginner strained carrots
25,760 cases of 2.5oz jars
(Heinz) Product contains elevated levels of lead 20-22ug/oz of lead/4oz jar (usual intake is 4.1ug of lead/day from food)

Manufacturer’s Voluntary Recall 1998 Beginner strained carrots, Vegetable chicken dinner: 300,000 jars
(Heinz)

II 1997 Gerber carrots for babies: 1st, 2nd,3rd foods; 2,141,880 jars
(Gerber)
Products contain high levels of arsenic

III 1997 Isomil Soy Formula, 104 cases, 6 cans per case (Ross) Did not contain the labeled amount of inositol. Product was originally formulated for distribution in the UK which did not require the addition of inositol

II 1997 Carnation Follow Up formula; 32 oz cans;
11,317 cases (6cans/ case)
(Nestle) Adulterated-produced under insanitary conditions; linked with mild gastrointestinal illness; product is separated

II 1996 Heinz Apple-Prune juice for infants; 4oz bottles
Contain lead in excess of 80ppb

1996
Market Withdrawel Carnation Alsoy Concentrate liquid, 13oz cans Carnation Nutritionals
(Nestle) Can top says “Do not add water” mislabeling could lead to infantsconsuming undiluted, concentrated formula (side label states to add water)

III 1996 Balsam Springs Baby Water with fluoride in gallon containers
(Veryfine Products) Unfit for food due to seal micro- leakage and contaminated with extraneous material

III 1996 Gerber Graduates apple juice for toddlers, 46oz clear, plastic bottles (Gerber)
Unfit for food due to vinegary and sour taste

III 1995 Oral water nursette, 3oz glass bottles (Bristol-Myers Squibb)
product contaminated with chlorine

II 1994 Carnation Good Start, concentrated liquid, 13oz cans; 16,878 cases
Carnation Nutritionals (Nestle)
Some cans contained non-pathogenic spoilage organisms indicating product could be contaminated with other microorganisms

III 1993 Infant’s Choice Water, calcium and fluoride added, sodium-free, in one gallon plastic jugs, 24,000 gallons, Magnetic Springs
Water Co., Columbus, Ohio
Product is mislabeled

I 1993 Soylac Powder infant formula, 14 oz cans, distributed in US
and Canada, (Nutricia, Inc)
Contaminated with Salmonella

I 1993 Promil, supplemental food for infants and children, distributed in Thailand, spray dried at Maple Island, Inc’s facility,
(Wyeth-Ayerst)
Manufactured under conditions where it may have become contaminated with Salmonella

I 1993 Formance, fortified nutritional powder for use by pregnant and lactating women, 850g cans, spray dried at Maple Island, Inc’s
facility, distributed in Hong Kong
(Ross Labs)
Manufactured under conditions whereby it may have become contaminated with Salmonella

II 1993 Nutramigen, 20 cal/oz, 3oz glass nursettes, 102,048 bottles
(Mead Johnson Nutritionals)

Contaminated with glass particles

II 1993 Gerber 2nd Foods brand oatmeal with applesauce and bananas, 4oz jars, 25,590 cases
(Gerber Products)
Product contained glass particles

III 1993 Isomil Soy Formula with iron, concentrated liquid, 13 oz cans,
(Ross Labs)
Product is in cans with peeling can liners

II 1993 Nursoy Soy Protein, iron fortified concentrate, 13 oz cans, 10,250 cases (Wyeth-Ayerst)
Some contaminated with Klebsiella pneumoniae and Pseudomonas aeruginosa: hazard to infant health in form of gastrointestinal stress to infants and newborns

I 1990 I-Soyalac Concentrated Infant Formula, 13oz cans (Loma Linda Foods)
Contaminated with heat sensitive and heat resistant bacteria

III 1989 Similac PM 60/40 powder, 16oz metal cans, low iron infant formula
(Ross Labs)
Deficient in vitamin D, below label claims for vitamin K

III 1989 Carnation Good Nature Infant Formula, 32oz containers, for babies over six months of age Unfit for food because of physical appearance and will not pass through an ordinary bottle nipple

III 1989 Nutramigen Iron Fortified Protein Hydrolysate Formula, 4 & 8oz bottles
(Mead Johnson)
Deficient in vitamin D

III 1986 Soyalac Powder, 1.2 oz foil pouches as physician samples
(Loma Linda Foods)
Progressive vitamin A degredation

II 1986 SMA Ready to Feed 32 oz cans
(Wyeth Labs)
Curdling, discoloration, off odor

II 1985 Gerber Meat Base Formula with iron, 15 oz cans of concentrated formula
Superpotent levels of vitamin A and subpotent levels of vitamin D

I 1985 Kama-Mil Powder, 14 & 16 oz cans
(Kama Nutritional Products) Marked in violation of Infant Formula Act, deficient in folacin, vitamin D and zinc

I 1985 Nutra-Milk Powder infant formula, 8, 10, & 16 oz bottles
-as above-

I 1985 Kama-Mil Powder infant formula in 14 oz fiberboard cans, 14 & 16oz
-as above-

I 1985 Pamphlet labeled in part “Edensoy” promotional material for EdensoySoy Drinks
(Eden Foods, Inc.)
Pamphlet erroneously suggests that Edensoy may be used as a substitute for mother’s milk or for infant formula

II 1985 Cow & Gate Improved Modified Infant Formula, 450 gm & 1 kg cans, US Virgin Islands
Deficient in copper & linoleic acid, not in compliance with section 412 of Food, Drug and Cosmetic Act

III 1985 Lactogen Brand Infant Milk Formula in powder form with iron, 450gm, 227 gm, & 1135 gm cans
(Cow & Gate)
-as above-

II 1985 5% glucose water in 4 oz bottles
(Ross Labs) Glass particles in product due to bottle necks chipping

III 1984 Similac with iron concentrate, 13 oz cans
(Ross Labs) Overprocessed resulting in its becoming lumpy, brown, and unfit for food consumption

II 1983 Soyalac Powder Milk-Free fortified soy formula, 16 oz cans
(Loma Linda Foods)
Deficient in vitamin A

II 1983 Naturlac Infant Formula Powder, 22 3/4 oz cans and trial size 32 gm packets
(Fillmore Foods) Copper levels below minimum required by Infant Formula Act, thiamine and vitamin B-6 below label declaration

I 1982 Nursoy Concentrated Liquid 13 oz cans, Nursoy Ready to Feed 32 oz cans
(Wyeth Labs)
Deficient in vitamin B-6

I 1982 SMA Iron Fortified Concentrated Liquid 13 oz cans, SMA Iron Fortified Ready to Feed 32 oz cans, SMA Powder 16 oz cans, SMA E-Z Nurser Ready to Feed Nursettes
(Wyeth Labs)
Deficient in vitamin B-6, less than stated on the label

Source: FDA Enforcement Report, HFI-20, 5600 Fishers Lane, Rockville, MD 20857
Class I Recall: A product whose use will cause serious health consequences or death
Class II Recall: A product whose use may cause medically reversible health consequences
Class III Recall: A product whose use is not likely to cause adverse health consequences

© 2001 Marsha Walker, RN, IBCLC

Recall Class Date	Product	Problem
Firm initiated Recall 2001	Carnation Follow-Up formula, 32 ounce liquid ready-to-feed; 120 cans (Nestle)	Excessive magnesium content in one batch; long term use could cause adverse health effects such as low blood pressure and irregular heart beat. The Product was distributed only to Wal*Mart stores in 19 cities in Texas.
Firm initiated allergy alert 2001	LactoFree and Enfamil AR sample packs. The LactoFree pack has two 3oz ready-to-use Nursette bottles and two Easy One single serving powder packets. The Enfamil AR sample contains three 3oz ready-to-use Nursette bottles and a single hole nipple (Mead Johnson)	Ingredients are not listed on the back of the boxes.These sample packs were distributed to physicians nationwide to give to their patients. Infants allergic to milk protein run the risk of a serious or life threatening allergic reaction if they consume these products
Firm Initiated Recall 2001	LactoFree sample packs containing two 3 ounce ready-to-use nursette bottles and two Easy One single serving powder packets (Mead Johnson)	Packages failed to list the ingredients on the back of the box. Infants allergic to milk protein are at risk of life threatening allergic reaction if they consume the product. The sample packs were shipped to 30 stores in nine states, Colorado, Iowa, Kansas, Louisiana, Minnesota, Missouri, Oklahoma, Texas, & Tennessee.
Firm Initiated Recall 2001	Nutramigen powder (3.7 million 16 oz cans) and Nutramigen ready to feed (930,000 32oz cans) (Mead Johnson)	The cans have incorrect preparation instructions in Spanish that could lead to seizures, an irregular heartbeat, or death if the altered formula is consumed for several days. Infants already ill or who live in hot climates are at greater risk for potentially fatal complications. The formula was distributed nationwide as well as in Guam, the Dominican Republic, and Puerto Rico. The offending product was permitted to remain on the shelves in stores, with correct preparation instructions in Spanish posted as tear off sheets that the consumer was responsible for noticing
III 2000 Firm-initiated recall	Repackaged infant formula: Isomil powder and concentrate; Similac with iron, low iron powder and concentrate; Neosure powder; Enfamil low iron and with iron powder, Enfamil Lacto-free powder; Prosobee soy powder; Nutramigen powder 2000-3000 cases	The infant formulas were repackaged in cardboard trays/boxes which are misbranded. All lots of cardboard cases and trays that were repackaged, labeled, and distributed by Unity Wholesale Grocery since April 25, 2000
III 2000	Carnation Good Start, Alsoy, and Follow-up in 13oz concentrate cans (2.5 million cans) (Nestle)	Processing may not have reached high enough temperatures to ensure sterility
II 1999	Isomil ready to feed soy formula in 32 oz metal cans; 17,821 cases (106,926 cans) (Ross Laboratories)	Product was held in cans with a low level of can lid defects allowing for post-processing contamination
Manufacturer’s Voluntary Recall	ProSobee soy formula; 8oz, ready to use cans sold in 4-pack cartons; case potential to (Mead Johnson)	Cans in the batch mislabeled ProSobee when they Voluntary Recall actually contained vanilla Sustacal, an adult 7000nutrition supplement. Consuming Sustacal has the cause severe medical problems in infants, especially if they are ill, highly sensitive to milk proteins or have galactosemia. Because it has a higher caloric density and renal solute load as compared to ProSobee, Sustacal also has the potential to cause dehydration in healthy infants.
I 1999	Heinz 3 Broccoli, Carrots and Cheese Junior Baby Food; 6oz glass jars; 5,269 cases (24 jars/ case) (Heinz USA)	Product contaminated with pieces of hard plastic
III 1999	Carnation Follow-Up formula; 32 oz cans; 12,651 cases (6 cans/ case) (Nestle USA)	Product has a lumpy, curdled appearance
II 1998	Beginner strained carrots 25,760 cases of 2.5oz jars (Heinz)	Product contains elevated levels of lead 20-22ug/oz of lead/4oz jar (usual intake is 4.1ug of lead/day from food)
Manufacturer’s Voluntary Recall 1998	Beginner strained carrots, Vegetable chicken dinner: 300,000 jars (Heinz)
II 1997	Gerber carrots for babies: 1st, 2nd,3rd foods; 2,141,880 jars (Gerber)	Products contain high levels of arsenic
III 1997	Isomil Soy Formula, 104 cases, 6 cans per case (Ross)	Did not contain the labeled amount of inositol. Product was originally formulated for distribution in the UK which did not require the addition of inositol
II 1997	Carnation Follow Up formula; 32 oz cans; 11,317 cases (6cans/ case) (Nestle)	Adulterated-produced under insanitary conditions; linked with mild gastrointestinal illness; product is separated
II 1996	Heinz Apple-Prune juice for infants; 4oz bottles	Contain lead in excess of 80ppb
1996 Market Withdrawel	Carnation Alsoy Concentrate liquid, 13oz cans Carnation Nutritionals (Nestle)	Can top says “Do not add water” mislabeling could lead to infantsconsuming undiluted, concentrated formula (side label states to add water)
III 1996	Balsam Springs Baby Water with fluoride in gallon containers (Veryfine Products)	Unfit for food due to seal micro- leakage and contaminated with extraneous material
III 1996	Gerber Graduates apple juice for toddlers, 46oz clear, plastic bottles (Gerber)	Unfit for food due to vinegary and sour taste
III 1995	Oral water nursette, 3oz glass bottles (Bristol-Myers Squibb)	product contaminated with chlorine
II 1994	Carnation Good Start, concentrated liquid, 13oz cans; 16,878 cases Carnation Nutritionals (Nestle)	Some cans contained non-pathogenic spoilage organisms indicating product could be contaminated with other microorganisms
III 1993	Infant’s Choice Water, calcium and fluoride added, sodium-free, in one gallon plastic jugs, 24,000 gallons, Magnetic Springs Water Co., Columbus, Ohio	Product is mislabeled
I 1993	Soylac Powder infant formula, 14 oz cans, distributed in US and Canada, (Nutricia, Inc)	Contaminated with Salmonella
I 1993	Promil, supplemental food for infants and children, distributed in Thailand, spray dried at Maple Island, Inc’s facility, (Wyeth-Ayerst)	Manufactured under conditions where it may have become contaminated with Salmonella
I 1993	Formance, fortified nutritional powder for use by pregnant and lactating women, 850g cans, spray dried at Maple Island, Inc’s facility, distributed in Hong Kong (Ross Labs)	Manufactured under conditions whereby it may have become contaminated with Salmonella
II 1993	Nutramigen, 20 cal/oz, 3oz glass nursettes, 102,048 bottles (Mead Johnson Nutritionals)	Contaminated with glass particles
II 1993	Gerber 2nd Foods brand oatmeal with applesauce and bananas, 4oz jars, 25,590 cases (Gerber Products)	Product contained glass particles
III 1993	Isomil Soy Formula with iron, concentrated liquid, 13 oz cans, (Ross Labs)	Product is in cans with peeling can liners
II 1993	Nursoy Soy Protein, iron fortified concentrate, 13 oz cans, 10,250 cases (Wyeth-Ayerst)	Some contaminated with Klebsiella pneumoniae and Pseudomonas aeruginosa: hazard to infant health in form of gastrointestinal stress to infants and newborns
I 1990	I-Soyalac Concentrated Infant Formula, 13oz cans (Loma Linda Foods)	Contaminated with heat sensitive and heat resistant bacteria
III 1989	Similac PM 60/40 powder, 16oz metal cans, low iron infant formula (Ross Labs)	Deficient in vitamin D, below label claims for vitamin K
III 1989	Carnation Good Nature Infant Formula, 32oz containers, for babies over six months of age	Unfit for food because of physical appearance and will not pass through an ordinary bottle nipple
III 1989	Nutramigen Iron Fortified Protein Hydrolysate Formula, 4 & 8oz bottles (Mead Johnson)	Deficient in vitamin D
III 1986	Soyalac Powder, 1.2 oz foil pouches as physician samples (Loma Linda Foods)	Progressive vitamin A degredation
II 1986	SMA Ready to Feed 32 oz cans (Wyeth Labs)	Curdling, discoloration, off odor
II 1985	Gerber Meat Base Formula with iron, 15 oz cans of concentrated formula	Superpotent levels of vitamin A and subpotent levels of vitamin D
I 1985	Kama-Mil Powder, 14 & 16 oz cans (Kama Nutritional Products)	Marked in violation of Infant Formula Act, deficient in folacin, vitamin D and zinc
I 1985	Nutra-Milk Powder infant formula, 8, 10, & 16 oz bottles	-as above-
I 1985	Kama-Mil Powder infant formula in 14 oz fiberboard cans, 14 & 16oz	-as above-
I 1985	Pamphlet labeled in part “Edensoy” promotional material for EdensoySoy Drinks (Eden Foods, Inc.)	Pamphlet erroneously suggests that Edensoy may be used as a substitute for mother’s milk or for infant formula
II 1985	Cow & Gate Improved Modified Infant Formula, 450 gm & 1 kg cans, US Virgin Islands	Deficient in copper & linoleic acid, not in compliance with section 412 of Food, Drug and Cosmetic Act
III 1985	Lactogen Brand Infant Milk Formula in powder form with iron, 450gm, 227 gm, & 1135 gm cans (Cow & Gate)	-as above-
II 1985	5% glucose water in 4 oz bottles (Ross Labs)	Glass particles in product due to bottle necks chipping
III 1984	Similac with iron concentrate, 13 oz cans (Ross Labs)	Overprocessed resulting in its becoming lumpy, brown, and unfit for food consumption
II 1983	Soyalac Powder Milk-Free fortified soy formula, 16 oz cans (Loma Linda Foods)	Deficient in vitamin A
II 1983	Naturlac Infant Formula Powder, 22 3/4 oz cans and trial size 32 gm packets (Fillmore Foods)	Copper levels below minimum required by Infant Formula Act, thiamine and vitamin B-6 below label declaration
I 1982	Nursoy Concentrated Liquid 13 oz cans, Nursoy Ready to Feed 32 oz cans (Wyeth Labs)	Deficient in vitamin B-6
I 1982	SMA Iron Fortified Concentrated Liquid 13 oz cans, SMA Iron Fortified Ready to Feed 32 oz cans, SMA Powder 16 oz cans, SMA E-Z Nurser Ready to Feed Nursettes (Wyeth Labs)	Deficient in vitamin B-6, less than stated on the label