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FDA alert to not buy or consume the Mother’s Touch infant formula

1 year ago

United States

The FDA advises parents and caregivers not to buy or give Mother’s Touch Formula to infants under their care because we have determined that this brand of infant formula is being marketed without pre-market notification to the FDA and has not been properly tested for the presence of potentially harmful bacteria. Additionally, nutrient label claims on the product label showed the product to contain nutrient amounts below the minimum levels required for protein, linoleic acid, calcium, sodium, potassium, and chloride; and above the maximum level allowed for iron.

The affected product is Mother’s Touch Formula. It is sold at local markets in Kinzers, Loganton, and Gap, PA and was available for purchase directly from Mother’s Touch website.

The FDA has determined that Mother’s Touch Formula is not manufactured in compliance with the FDA’s infant formula regulations. In addition, the product was not fully tested for the presence of potentially harmful bacteria such as Cronobacter.

Parents and caregivers of infants who have purchased this product should discontinue use and throw it away. Parents and caregivers of infants who have used this product and are concerned about the health of their child should contact their health care provider.

If your infant is experiencing symptoms after eating the product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Source: www.fda.gov/food/alerts-advisories-safety-information/fda-advises-parents-and-caregivers-not-buy-or-give-mothers-touch-formula-infants

303


Related Reports

Reckitt has taken the precautionary step of recalling Nutramigen LGG stage 1 and stage 2 Hypoallergenic Formula powders because of the possible presence of Cronobacter sakazakii. Both products are foods used for special medical purposes for infants. These products were distributed in the United Kingdom.

The recalled... See More products are
- Nutramigen LGG Stage 1 Hypoallergenic Formula (400g), Batch code ZL3F7D, Best before: 01 July 2025
- Nutramigen LGG Stage 2 Hypoallergenic Formula (400g), Batch code ZL3FAA, Best before: 01 July 2025
- Nutramigen LGG Stage 2 Hypoallergenic Formula (400g), Batch code ZL3FDM, Best before: 01 July 2025

The products are mainly prescribed but are also available without a prescription.

If you have purchased or been prescribed any of the affected product batches, do not feed it to your baby and return to the place of purchase.

Symptoms caused by Cronobacter sakazakii usually include fever and diarrhea, and in severe cases may lead to sepsis or meningitis which include symptoms in infants including poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes) and abnormal breaths and movements.

If your infant is experiencing symptoms after eating the product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Reckitt
Brand name: Nutramigen LGG
Product recalled: Nutramigen LGG Stage 1 Hypoallergenic Formula, Nutramigen LGG Stage 2 Hypoallergenic Formula, Nutramigen LGG Stage 2 Hypoallergenic Formula
FSA Recall date: 01/02/2024

Source: www.food.gov.uk/news-alerts/alert/fsa-prin-01-2024
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Update January 04, 2024

The FSAI published an update for the recall. They have become aware that the majority of this product has been sold by pharmacies.

Retailers, including pharmacies, are requested to remove the implicated batches from sale and display recall notices at point-of-sale.

Consumers are... See More advised not to consume the implicated batch. If you have the batch numbers of the product listed above, you can return it to the pharmacy that dispensed it to you for a refund.

Source: www.fsai.ie/news-and-alerts/food-alerts/updated-recall-of-nutramigen-lgg-stage-1-2-hypoall

January 02, 2024

The FSAI announced the recall of Nutramigen LGG Stage 1 & 2 by Reckitt/Mead Johnson Nutrition due to the possible presence of Cronobacter sakazakii. These products were distributed in Ireland.

The recalled products are:
- Nutramigen LGG Stage 1, 400g, Batch code: ZL3F7D
- Nutramigen LGG Stage 2, 400g, Batch code: ZL3FAA and ZL3FDM

Cronobacter sakazakii infections are rare but they can be serious for babies younger than 2 months or babies born prematurely or immunocompromised. Illness usually starts with a fever and poor feeding, excessive crying, or very low energy. In severe cases, it may lead to sepsis or meningitis.

Do not feed your infant with the recalled products.

If your infant is experiencing symptoms after eating the product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Source: www.fsai.ie/news-and-alerts/food-alerts/recall-of-nutramigen-lgg-stage-1-2-baby-formula-du
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Enfamil brand Nutramigen A+ LGG Hypoallergenic (infant formula) recalled due to possible presence of Cronobacter sakazakii. The affected products are being recalled from the marketplace due to possible Cronobacter sakazakii contamination. This product is distributed nationally. There have been no reported illnesses associated with the consumption of... See More these products.

-Affected products:
Brand: Enfamil, Product: Nutramigen A+ LGG Hypoallergenic (infant formula), Size: 561 g, UPC: 0 56796 00498 2, Codes: Item# 3230626; Expiry 01-JA-2025; Batch # 0704376 (ZL3FVY)

Brand: Enfamil, Product: Nutramigen A+ LGG Hypoallergenic (infant formula), Size: 4 x 561 g, UPC: 0 56796 00498 5, Codes: Item# 3230626; Expiry 01-JA-2025; Batch # 0704376 (ZL3FVY)

If you think you became sick from consuming a recalled product, contact your healthcare provider; Check to see if you have recalled products

Do not consume, serve, use, sell, or distribute recalled products

Recalled products should be returned to the location where they were purchased

Food contaminated with Cronobacter sakazakii may not look or smell spoiled but can still make you sick. Although Cronobacter sakazakii is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter sakazakii can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns.

If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Mead Johnson Nutrition (Canada) Co.
Brand name: Enfamil
Product recalled: Nutramigen A+ LGG Hypoallergenic (Infant Formula)
Reason of the recall: Issue Food - Microbial Contamination - Other
CFIA Recall date: 2023-12-31

Source: recalls-rappels.canada.ca/alert-recall/enfamil-brand-nutramigen-lgg-hypoallergenic-infant-formula-recalled-due-possible
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Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced today that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, due... See More to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria. No illnesses or adverse consumer reactions have been reported to date. The products were distributed through retail stores nationwide.

Company Announcement All product tested by MJN was confirmed negative for contaminants.
No Nutramigen liquid formulas or any other Reckitt nutrition products are impacted.

Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023. Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed. There are no reports of illnesses or adverse events to date. The batches in question can be identified by the batch code on the bottom of the can.

The following recalled product batch codes and can size associated with each batch were distributed in the U.S.: ZL3FHG (12.6 oz cans);
ZL3FMH (12.6 oz cans);
ZL3FPE (12.6 oz cans);
ZL3FQD (12.6 oz cans);
ZL3FRW (19.8 oz cans); and
ZL3FXJ (12.6 oz cans).
The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

No other U.S. distributed Nutramigen batches or other Reckitt products are impacted.

Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products.

Consumers who purchased Nutramigen should check the bottom of the can to identify whether the batch number is affected. Product with the batch codes listed above customer should contact us for a total refund.

Company name: Reckitt/Mead Johnson Nutrition
Brand name: Enfamil
Product recalled: Nutramigen Powder infant formula in 12.6 and 19.8oz cans
Reason of the recall: Potential Cronobacter sakazakii contamination
FDA Recall date: December 31, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckittmead-johnson-nutrition-voluntarily-recalls-select-batches-nutramigen-hypoallergenic-infant
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303


FDA announced the recall of Parent's Choice brand Sensitivity Premium and Tippy Toes brand Sensitivity Premium Infant Formulas by PBM Nutritionals, LLC due to the Inadvertent release of rejected product to market. These products were distributed in IL, AL, IA, GA, MS, IN, AR, CO, FL, VA,... See More OH, WI, PA, NH, AZ, KS, TX, TN, NC, LA, MO, KY, DE, and WI.

The recalled products are Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cans. Code Information: D05LVJV USE BY 05MAR2025 D06LT7VA USE BY 06MAR2025 UPC Codes: 36800496644 and 681131045513

This recall was initiated on 6/16/2023 and its status is ongoing. Do not consume, use, sell, serve, or distribute the recalled products.

In case your baby experiences harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care

Source: www.accessdata.fda.gov/scripts/ires/index.cfm?Product=201716
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90


Suspected food poisoning. Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps
Suspected source: Sandwich from Jimmy Johns
Onset: 4 to 12 hours
Duration: 4 to 12 hours
Sick: Me | Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps See Less


Just now Slim jim I am currently starting to get more and more sick, stomach cramps | Symptoms: Cramps, Vomiting, Nausea, Diarrhea, Other See Less


Suspected food poisoning. Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps, Headache
Suspected source: i honestly do not know but i had some microwaved shrimp alfredo and i think thats it
Onset: Less than 4 hours
Duration: Several days
Sick: Me | Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps, Headache See Less


Suspected food poisoning. Symptoms: Nausea
Suspected food poisoning. Symptoms: Nausea
Suspected source: Chicken
Onset: Less than 4 hours
Duration: Less than 4 hours
Sick: Me | Symptoms: Nausea See Less


Suspected food poisoning. Symptoms: Diarrhea, Nausea, Fever, Stomach Pain, Cramps, Chills
Suspected source: Not sure
Onset: Less than 4 hours
Duration: 4 to 12 hours
Sick: Me | Symptoms: Diarrhea, Nausea, Fever, Stomach Pain, Cramps, Chills See Less


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Amy's Kitchen has voluntarily recalled its Enchilada Verde Whole Meal, sold at Publix and Publix GreenWise Market, due to potential listeria contamination.
The issue was discovered following a recall notice from cheese supplier Rizo-Lopez Foods, Inc., who alerted Amy's Kitchen to the possible presence of Listeria in... See More the cheese used in the Enchilada Verde Whole Meal. No illnesses related to the recalled products have been reported, and the recall is being conducted out of an abundance of caution. The FDA has been notified of the voluntary recall.

The recalled product is Amy's Kitchen Enchilada Verde Whole Meal, with GTIN 4227200085 and best before dates of 4/24, 8/24, and 10/24. The recall affects three batches of the meal, which contains cheese potentially contaminated with Listeria monocytogenes.

If you purchased the affected products, we recommend returning them to the store where they were purchased.

Listeria monocytogenes is a type of bacterium that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriage and stillbirths among pregnant women.

In case you are experiencing Listeria monocytogenes symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: corporate.publix.com/newsroom/recalls/amys-kitchen-enchilada-verde-whole-meal#:~:text=This%20recall%20is%20based%20on,the%20Enchilada%20Verde%20Whole%20Meal.
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672


I got diarrhea and vomiting last night past 12am after eating 4 cups of Snack Pack Chocolate Vanilla pudding. After that I had cold chills but am better today. Pudding bought from Amazon.. I bought the pudding from Amazon. The package label says Chicago, Illinois. I got... See More diarrhea and vomited at the same time after eating a 4th cup of pudding in one hour. | Symptoms: Diarrhea, Vomiting, Chills See Less


Chick-fil-A has issued a food alert for its Polynesian Sauce dipping cups, following concerns that they may contain wheat and soy allergens. The alert affects customers who took home the sauce between February 14-27, 2024.

The company discovered that the cups may contain a different sauce, which... See More includes wheat and soy allergens. This could pose a risk to individuals with allergies or sensitivities to these ingredients.

In case you experience harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: www.chick-fil-a.com/
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303


I purchased Amys Pad Tai at Food Lion Forest City, NC I ate it around Noon. By midnight I was vomiting every 45 min all throughout the night into the morning. Was horrific! | Symptoms: Vomiting See Less
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I asked for extra hot on the spicy lvl they gave me regular some bullsh*t no napkins no sauce I drove 25 min just to buy this crap, food was cold, fries were cold some lazy a*s employees ya got working at this location… Someone took my... See More order and it was all wrong the shake I ordered tasted spoiled couldn’t even drink it…. Straight up trash will never be back at this location | Symptoms: Vomiting See Less
746


Suspected food poisoning. Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps
Suspected source: Chicken sandwich
Onset: 4 to 12 hours
Duration: 12 to 24 hours
Sick: Me
Additional information: I ate a chicken sandwich from KFC at 1:00pm on 3/17/24 and at 5:00pm on 3/17/24 I started experiencing severe... See More cramps, nausea, vomiting, and diarrhea | Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps See Less
399


I ate breakfast for the first time at that hotel (Mexican-style eggs, beans, fruit, coffee) on March 20 around 9 am and I started to feel a sore stomach since noon, I didn't eat anything else until 4 pm and at 5 I started vomiting and having... See More unstoppable diarrhea, the next day I couldn't even get out of bed and I'm still sick. My husband ate the same breakfast and a few hours after I started having diarrhea and vomiting he also started having diarrhea for 2 days, he is already feeling well. | Symptoms: Nausea, Diarrhea, Vomiting, Soreness See Less
90


Requested a rarely ordered dish at the noddle restaurant. Within 3 hours u felt bloated and uncomfortable. Went to bed, woke up feeling bloated. Laid in bed all morning and by the afternoon was vomiting multiple times. Called security who then called an ambulance. Went to ER,... See More tested for flu etc and was all clear. Doctor decided I had an GI Bug. Got hydrated, given meds to my stomach, released. hotel sent security to pick me up. Have been in bed since | Symptoms: Nausea, Vomiting, Bloating See Less
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Suspected food poisoning. Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps
Suspected source: Buffalo wings
Onset: 4 to 12 hours
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474


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