Recalls and Alerts: August 29–30, 2023

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

OUTBREAK INVESTIGATION: FDA has initiated traceback investigations for a new outbreak of Salmonella Newport (8 cases) and Cryptosporidium (11 cases), each linked to a not yet identified product. The eleven Cryptosporidium cases are all reported from Minnesota, and the FDA is assisting the Minnesota Department of Health and Minnesota Department of Agriculture in their investigation.

Food Safety Recall: Dean & Peeler Meatworks, LLC recalls approximately 1,835 pounds of fresh ground beef products due to possible E. coli O157:H7 contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: The Ice Cream House recalls all Dairy Ice Cream Products and Non-dairy [Parve] frozen Dessert products due to possible Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: TODORGANIC INC recalls Nuez de la India Seeds (12 seeds/2-oz bag) because FDA analysis has determined that the seeds appear to be Thevetia peruviana, or yellow oleander. All parts of the yellow oleander plant are known to contain cardiac glycosides that are highly toxic to humans and animals.

Food Safety Alert: FDA is advising consumers not to eat, and restaurants and food retailers not to sell, and to dispose of cultured mussels from East River Shellfish, Inc. from harvest location PE 4-C, harvested on 8/14/2023, and shipped on 8/15/2023 to retailers in IL, MA, and NY due to the possible presence of Salmonella and E. coli.

FDA Warning Letters—Infant Formula Manufacturers: FDA issues Warning Letters to ByHeart, Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations. The Warning Letters reflect findings from FDA inspections of these facilities over the last several months.

Canada

Allergy Alert: FTG Foods Canada Ltd. recalls Kikiam Sticks (~1 kg; Batch no. 02230523; Best before 2025 May 23) and Viva brand Kikiam Sticks – Seafood Sticks (300g; Lot 232843; Best before 25 FE 03; UPC 6 91835 06615 8) due to undeclared egg.

Food Safety Recall: S. Shivji Ventures Ltd. recalls BodyArmor brand Super Drink and BodyArmor brand Lyte (All sizes, flavours, and codes) due to over-fortification of vitamins and minerals and labelling issues.

Food Safety Recall Update: Industry recalls various brands of caffeinated energy drinks due to caffeine content and labelling issues. Please refer to the recall notice for a complete list of affected products.

Europe

OUTBREAK INVESTIGATION UPDATE (Multiple EU countries): Eleven EU countries have reported a total of at least 134 human cases from two outbreak clusters of Salmonella Enteritidis linked to consumption of a number of chicken dishes, including kebab, pizza, burritos and schnitzel. As of August 29, 2023, the number of confirmed cases in Denmark has been increased to twenty-two.

Allergy Alert (Belgium): Albert Heijn recalls Albert Heijn brand Indisch gekruide gehaktballetjes / Indian spiced meatballs (110g; Best before 06-09-2023) due to undeclared gluten (wheat).

Allergy Alert (Belgium): La Box des Amis recalls multiple products due to undeclared allergens. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (Belgium): SG Centrale SRL recalls Sueda brand Persil – feuilles séchées / Dried parsley leaves (500g; Lot E0003808; Best before 31/05/2025) due to undeclared celery.

Allergy Alert (Italy): CONSORZIO PRODUTTORI LATTE S.A.C. recalls Gelato di Romagna gusto ¿Spagnola¿ (Gelato alla panna variegato con amarene) Barattolo / Black cherry-flavored gelato (500g; Lot L23193; Best before 07/2025) due to undeclared milk.

Allergy Alert (Netherlands): Albert Heijn recalls AH brand Indisch gekruide gehaktballetjes / Indian spiced meatballs (110g; Best before 06-09-2023) due to undeclared gluten (wheat).

Allergy Alert (UK): Funbel Ventures Ltd recalls OLA-OLA Authentic Pounded Yam (1.8kg, 4.5kg, 907g; All batch codes; All Best before dates from 2020) due to undeclared milk and sulphites.

Food Safety Recall (Belgium): Match S.A. recalls Jean Routhiau brand Emincés de filets de poulet Tikka / Sliced Tikka chicken filets (150g; Lot 3 233 01; Expiry date 18/09/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (Denmark): King Food recalls Ana Food forstegt kyllingekebab / Pre-fried chicken kebab (2 kg; Batch D2523; Best before 21.06.2024) due to Salmonella contamination.

Food Safety Recall (France): COOPERATIVE ISIGNY-SAINTE MERE recalls le Capipontain brand Camembert au lait microfiltré de vache / Camembert made from microfiltered cow’s milk (210g; Lot C1912; Best before 05/09/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (France): DUPRE SEBASTIEN recalls les délices du Gaulois brand pâté de tête / Head cheese pâté (Sold by the slice; Lot 53) due to Listeria monocytogenes contamination.

Food Safety Recall (France): AUCHAN recalls COQUES MOYENNES / Medium shells (Sold at fish stand from 22/08/2023 to 26/08/2023) due to E. coli contamination.

Food Safety Recall (France): SILVE INTERMARCHE recalls COQUES MOYENNES / Medium shells (Sold at fish stand from 23/08/2023 to 26/08/2023) due to E. coli contamination.

Food Safety Recall (France): CARREFOUR FRANCE recalls Carrefour sensation brand Gamme de cuisse avec portion de dos de poulet à la provençale / Chicken thighs with portion of back, Provençal style (500g & 1 kg; Lot 0093026060; Use by 14/08/2023, 17/08/2023 & 18/08/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (France): SILVE INTERMARCHE recalls SELLES SUR CHER AOP / cheese (150g; Lot S222T2; Best before 10/10/2023) due to E. coli O26 and E. coli O103 contamination.

Food Safety Recall (France): SILVE INTERMARCHE recalls Clos Chevrel brand SELLES SUR CHER AOP / cheese (150g; Lot S222T2; Best before 10/10/2023) due to E. coli O26 and E. coli O103 contamination.

Food Safety Recall (France): SILVE INTERMARCHE recalls Itinéraire de nos Régions brand SELLES SUR CHER AOP / cheese (150g; Lot S220T2; Best before 07/10/2023) due to E. coli O26 and E. coli O103 contamination.

Food Safety Recall (France): SCAMARK E.LECLERC recalls NOS REGIONS ONT DU TALENT brand CAMEMBERT D’ISIGNY AU LAIT MICROFILTRE DE VACHE / Camembert made from microfiltered cow’s milk (250g; Lot C1912; Best before 05/09/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (Germany): Schne-frost Produktion GmbH & Co. KG recalls Schupfnudeln, Knusper-Kroketten, Kartoffel-Kroketten, Gnocchi / Schupfnudeln, crispy croquettes, potato croquettes and gnocchi (2.5 kg; Various lot codes; Best before 02/2025) due to foreign matter contamination (metal pieces).

Food Safety Recall (Germany): Thanh Long Food and Thin Son Handel GmbH recalls Mu-Err-Pilze in Streifen / Mushroom strips (1 kg; Putative expiry date 20 12 24) due to Salmonella contamination.

Food Safety Recall (Germany): NORFISK GmbH recalls Gut&Günstig brand Norwegischer Stremel Lachs heiß geräuchert Natur / Norwegian stremel hot-smoked salmon, plain (125g; Lot L34232531/20; Use by 02.09.2023) due to Listeria monocytogenes contamination.

Food Safety Recall (Germany): Hofkäserei Belrieth recalls various soft cheeses due to Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Luxembourg): ALVA recalls Fromage de chèvre au lait cru SELLES-SUR-CHER / Raw goat’s milk cheese (150g; Lot 0621853243; Best before 31/08/2023) due to possible Listeria monocytogenes contamination.

Food Safety Recall (Romania): Cedrob S.A. recalls Sferturi posterioare de pui congelate / Frozen chicken hindquarters (10 kg; Lot 228/3/23; Expiry 16.08.2025; Product of Poland) due to Salmonella Enteritidis contamination.

Asia, Africa and the Pacific Islands

Food Safety Recall (Hong Kong): MUSE DIGITAL LIMITED recalls Nutri D-Day DIET brand Oatmeal Shake (25g per pouch x 14 pouches; Best before February 5, 2025; Product of Korea) due to Salmonella contamination.

Food Safety Recall (Hong Kong): GOURMET EN PROVENCE LIMITED recalls XAVIER brand PALET DU BERRY goat cheese (150g; Lots 3288624, 3319239, 3319293; Best before August 10, 2023; August 25, 2023 and August 31, 2023; Product of France) due to possible Listeria monocytogenes contamination.

Australia and New Zealand

Allergy Alert (Australia): Sweets and Beverages Australia Pty Ltd recalls Akai Bohshi Kukkia Cookies (12P, 93.6g; Best before 2024.02.08) due to undeclared egg, almond and soy.

Food Safety Recall (New Zealand): Aldiery’s Mediterranean Market Ltd recalls Durra brand Tahina (400g & 800g; Expiry date 24/03/25) due to possible Salmonella contamination.

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Nine baby deaths reported to FDA during Abbott Nutrition investigation

Between December 1, 2021, and March 3, 2022, the US Food and Drug Administration (FDA) received nine (9) reports of infant deaths among babies who were fed powdered infant formula manufactured by Abbott Nutrition in Sturgis, Michigan.

The infant death reports were included in a list of 128 consumer complaints supplied to eFoodAlert by the FDA in response to a Freedom of Information Act (FOIA) request. (see: Abbott Nutrition consumer complaints file, Redacted)

Two of the deaths were numbered among the four confirmed outbreak cases of Cronobacter sakazakii identified by the US Centers for Disease Control and Prevention (CDC).

The other seven deaths were reported to the FDA via the agency’s consumer complaint system. Two of those reports mentioned Salmonella in the complaint description.

In addition to the nine deaths, consumers described twenty-five (25) incidents categorized as “Life Threatening Illness/Injury” and eighty (80) instances of “Non-Life Threatening Illness/Injury.”

Fourteen consumers contacted the FDA to obtain information or clarifications on the Abbott recall.

The complaints were lodged with FDA District Offices across the continental USA.

Salmonella was present in two of the dead babies, and was mentioned in seventeen other illness complaints.

One of the surviving infants was infected with both Salmonella and E. coli.

The symptoms suffered by the infants were mostly consistent with a gastrointestinal infection: fever (31 babies), vomiting (42 babies), diarrhea (47 babies), and blood in stool (6). Most babies suffered from multiple symptoms.

Other reported symptoms included loss of appetite, rash (either localized or spread over entire body), lethargy, dehydration, irritability, weight loss, and difficulty breathing.

Some of the infants suffered from multiple infections:

Cronobacter sakazakii and Proteus mirabilis
Covid-19 and Salmonella
CDIFF (Clostridioides difficile) and Salmonella
Salmonella and Shigella
Salmonella, astrovirus, and “shigelloides”

The FDA did not respond to eFoodAlert‘s request for comment on what was done to follow up on the seven infant death reports that did not involve Cronobacter sakazakii, or on the non-fatal illnesses not involving Cronobacter.

According to an agency spokesperson, the FDA, along with the CDC and state and local partners, investigated consumer complaints and/or reports, received from September 20, 2021 to February 24, 2022, of infant illness.

The spokesperson did not address any of the more than thirty complaints–including three reported deaths–received by FDA district offices between February 25, 2022 and March 3, 2022.

Two of those three reported deaths referred to Salmonella.

The FDA investigation uncovered multiple instances of Cronobacter sakazakii in the environment of Abbott’s manufacturing facility.

None of the cultures retrieved from environmental samples were a genetic match for the strain that infected the two babies for which the CDC received cultures. The CDC did not receive cultures from the other two infected babies for genetic analysis.

Although there is no direct evidence in the form of genome sequencing to link any of the illnesses unequivocally to Abbott’s infant formulas, all of the complaints have one element in common.

Every one of the sick babies was fed an Abbott powdered formula.

The FDA has established an Incident Management Group (IMG) under Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

The IMG is tasked with managing the ongoing investigation and monitoring the infant formula supply chain, and will remain in place at least until the current supply shortage is over, according to the FDA spokesperson.

In Memoriam

With production now having resumed–under close supervision–at the Abbott Nutrition plant in Sturgis, the time has come to acknowledge the lives that were lost.

We know very little about the nine infants who died. For privacy reasons, their names, ages, genders, where they lived, and when they died have been withheld. They are identified only by their unique Complaint ID numbers.

Complaint ID #171222, reported December 1, 2021. Infant arrived to the ER in cardiac arrest. Cronobacter sakazakii and Proteus mirabilis. Infant had consumed Similac Pro-Total Comfort (Powder) infant formula, Lot #23495K80.
Complaint ID #172435, reported February 22, 2022. Vomiting, swollen organs, trouble breathing. Infant had consumed Similac Advance, Lot #34875K80.
Complaint ID #172477, reported February 22, 2022. Screaming. Infant had consumed Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, et al, infant formula powder, Lot #34869K80.
Complaint ID #172479, reported February 23, 2022. Fever, diarrhea, loss of appetite, vomiting. Infant had consumed Similac Advanced infant formula. Lot number not available.
Complaint ID #172541, reported February 24, 2022. Tested positive for Cronobacter sakazakii. Infant had consumed Similac PM 60/40, Lot #27032K800.
Complaint ID #172585, reported February 24, 2022. No details available. Infant had consumed EleCare infant formula, Lot number not available.
Complaint ID #172607, reported February 28, 2022. Cause of death and opinion pending further studies (Congenital). Infant had consumed Similac Elecare powdered infant formula, Lot #34771Z21 1306305
Complaint ID #172632, reported March 2, 2022. Salmonella meningitis, ventriculitis, vomit, diarrhea, seizures, bradycardia. Infant had consumed Similac Pro Advance infant formula, Lot #25598SHO 0557 015 SIMESPWD.
Complaint ID #172636, reported March 2, 2022. Salmonella. Infant had consumed Similac Total Comfort, Lot #26834K80.

May they rest in peace.

Abbott’s senior vice president grilled by members of House subcommittee

This story by Coral Beach first appeared at Food Safety News and is reposted here with permission

“We know we let you down.”

The senior vice president of Abbott Nutrition — the manufacturer of infant formula whose plant closure amid a food safety investigation has left the country in dire straits with parents scrambling to find food for their babies — opened his testimony before a U.S. House panel Wednesday with that admission of guilt.

The day-long hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce was billed as an investigation into the infant formula shortage and the reasons behind it.

During the first half of the hearing members of the U.S. House of Representatives grilled top administrators from the Food and Drug Administration about the shortage and the agency’s investigation into Abbott’s Sturgis, MI, manufacturing plant. FDA Commissioner Robert Califf told the panel that the agency could have done a better job managing its investigation. (See our related story for complete coverage.)

The second half of the day was reserved for three executives from the baby food industry with about half of the time devoted to the shortage and the other half focusing solely on Abbott’s food safety status.

Abbott was represented by its senior vice president Christopher Calamari. Two other infant formula manufacturers also had top executives on hand to answer questions: Scott Fitz, vice president of Gerber, and Robert Cleveland, senior vice president of Reckitt. Together the three companies represent about 90 percent of the infant formula market in the United States. Abbott alone has 40 percent of the market.

Members of the House subcommittee questioned all three men about the status of infant formula production with little in the way of solutions offered for resolving the current shortage. All of the companies are working to meet the need with ramped-up production at U.S. plants. They are also working with the federal government to increase imports of infant formula.

As pressing as the need for more infant formula is, the reason behind the shortage received as much time in the spotlight as the shortage itself. If Abbott had not had to close down its Sturgis, MI, plant because of food safety issues there would not be a shortage.

Calamari repeatedly told the House subcommittee that Abbott is doing everything possible to get its plant up and running. It was closed down in mid-February when the company initiated a massive recall. The recall came amid an FDA investigation into links to a cronobacter outbreak that saw at least four babies hospitalized. Two of them died.

Time after time Calamari said that Abbott is “taking steps” to resolve food safety problems and make sure they don’t reoccur. Time after time the House members asked what the company is doing.

When Committee Chair Rep. Diana DeGette, D-CO, asked the question Calamari gave his generalized answer. DeGettee called him on it, seeking more specifics. The Abbott senior vice president then ticked off a handful of actions including replacing floors, repairing the roof, and changing the way personnel move through the 700,000-square-foot manufacturing plant.

During her closing remarks, the subcommittee chair remarked on the bipartisan outrage about the situation at the Abbott plant. She told Calamari that his answers had been “too vague.”

Highlights from other subcommittee members’ questions about the food safety situation and the answers from Calamari follow.

Rep. H. Morgan Griffith, R-VA
The ranking member of the subcommittee told Calamari that Abbott has more than a problem with its roof and floors. He cited a whistleblower document that reported managers hiding information from top corporate management and said the company has a “culture problem” and asked, “have any heads rolled?”

Calamari responded by saying he didn’t think it was a culture problem and that just last week he visited the Sturgis, MI, plant and met with multiple generations of employees there who are committed to producing safe infant formula.

Rep. Cathy McMorris Rodgers, R-WA
When the representative asked why there were cronobacter bacteria in the production facility Calamari said “it wasn’t in the production area,” adding that it is a naturally occurring bacteria. McMorris Rodgers asked Calamari what Abbott is doing to make sure its food safety issues do not recur he said the company “is committed to preventing future problems.”

Rep. Michael C. Burgess, R-TX
Burgess wanted to know when Abbott management was made aware of the whistleblower document. Calamari said they didn’t know about it until it was made public by Congress in April. He also said he did not want to speak to points made in the document because it is the subject of an ongoing investigation.

Rep. Kathleen M. Rice, D-NY
Rice also asked Calamari about the whistleblower document, wanting to know what measures Abbott has in place for employees to raise food safety concerns. Calamari said there is an “independent” entity within the company that takes and reviews employee concerns and that it was the whistleblower’s choice to not use the system to report concerns. Rice also asked what the company plans to do to make sure employees feel comfortable reporting issues and Calamari said the company would “encourage them to speak up.”

Rep. Janice D. Schakowsky, D-IL
Telling Calamari that she is “livid” about the situation and that the inspection report about the Sturgis, MI, plant is “disgusting,” Schakowsky asked him if he would take personal responsibility; he said “yes.”

Rep. Gary J. Palmer, R-AL
Calamari told Palmer that he was not aware of problems at the plant until FDA inspected it earlier this year. When Palmer asked why problems had not been addressed earlier Calamari said the company is committed to safety.

Rep. Scott H. Peters, D-CA
Peters asked how much of Abbott’s resources go toward food safety and Calamari said “tens of millions of dollars.” Peters then asked if it should be more. Calamari said, “we are committed to doing what it takes.”

Rep. Kim Schrier, D-WA
Schrier wanted to know why Congress should trust Abbott to fix problems at the production plant, especially in light of the whistleblower accusations of falsified records. Calamari said, “we are aligned with the FDA” on plans to reopen the plant.

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.