Food and Drugs Administration--Recalls/Safety Alerts http://www.fda.gov/ en Rocky Mountain Pies, LLC Issues Allergy Alert on Undeclared (Tree Nuts Almonds) in Red Button Vintage Creamery 31.88 oz French Silk Pie http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rocky-mountain-pies-llc-issues-allergy-alert-undeclared-tree-nuts-almonds-red-button-vintage Rocky Mountain Pies, LLC of Salt Lake City, Utah is recalling 31.88 oz French Silk Pie with inkjet code date 2 266, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to Tree Nuts (almonds) run the risk of serious or life-threatening allergic reaction if they Tue, 29 Nov 2022 17:53:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rocky-mountain-pies-llc-issues-allergy-alert-undeclared-tree-nuts-almonds-red-button-vintage Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022 http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50 Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the c Mon, 28 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50 Weis Markets Issues an Allergy Alert for Weis Quality Premium Sea Salt and Caramel Ripple Ice Cream Due to Undeclared Soy and Coconut Allergens http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/weis-markets-issues-allergy-alert-weis-quality-premium-sea-salt-and-caramel-ripple-ice-cream-due Weis Markets today said it has issued a recall for 108 containers of Weis Quality Sea Salt Caramel Ripple Ice Cream (48oz) since the product may contain undeclared soy and coconut allergens. People who have an allergy or severe sensitivity to soy or coconut allergens run the risk of serious or life- Wed, 23 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/weis-markets-issues-allergy-alert-weis-quality-premium-sea-salt-and-caramel-ripple-ice-cream-due Fudgeamentals Recalls Chocolate Fudge Bites Because of Undeclared Walnuts http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fudgeamentals-recalls-chocolate-fudge-bites-because-undeclared-walnuts Fudgeamentals of Melville, New York has voluntarily recalled one lot of Chocolate Fudge Bites packaged in 8 oz. plastic containers. The Chocolate Fudge Bites products may contain Chocolate Walnut Fudge Bites products instead, resulting in the presence of undeclared tree nut (walnut) ingredient. The Thu, 17 Nov 2022 13:32:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fudgeamentals-recalls-chocolate-fudge-bites-because-undeclared-walnuts Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/phils-power-pancake-issues-allergy-alert-undeclared-wheat-phils-power-pancake Phil’s Power Pancake of Costa Mesa, CA is recalling its 5 oz. packages of individually wrapped Power Pancakes in all 5 varieties (Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed) because they may contain undeclared wheat. People who have an allergy or severe sensitivity to wheat run Thu, 17 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/phils-power-pancake-issues-allergy-alert-undeclared-wheat-phils-power-pancake Green Day Produce, Inc. Recalls Enoki Mushrooms Because of Possible Health Risk http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-day-produce-inc-recalls-enoki-mushrooms-because-possible-health-risk Green Day Produce, Inc. of Vernon, CA is recalling its 200g/ 7.05oz packages of ENOKI MUSHROOM (Product of Korea) sold from September 2022 - October 2022 because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in Thu, 17 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-day-produce-inc-recalls-enoki-mushrooms-because-possible-health-risk Mason Vitamins Inc. Voluntary Recalls Healthy Sense Daily Multiple with Iron Tablets and People’s Choice Women’s Daily Vitamins with Iron Tablets Sold in the U.S Due to Inconsistent Product Labeling http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mason-vitamins-inc-voluntary-recalls-healthy-sense-daily-multiple-iron-tablets-and-peoples-choice Mason Vitamins Inc. has issued a nationwide voluntary recall of the specific lot of Healthy Sense Daily Multiple with Iron and People’s Choice Women's Daily Vitamins with Iron due to Vitamin A, Vitamin B12, Vitamin C, Vitamin E and Pantothenic Acid amounts being lower than the declared amount on the Thu, 17 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mason-vitamins-inc-voluntary-recalls-healthy-sense-daily-multiple-iron-tablets-and-peoples-choice Boston Baking Issues Allergy Alert on Undeclared Pecans in "Boston Baking Mini Cinnamon Crumb Cakes" http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boston-baking-issues-allergy-alert-undeclared-pecans-boston-baking-mini-cinnamon-crumb-cakes BOSTON BAKING, Inc. of Boston, MA, is recalling its 3-ounce, individually wrapped packages "Boston Baking Mini Cinnamon Crumb Cakes" food snacks sold exclusively at Whole Foods Market stores because they may contain undeclared pecans. People who have allergies to pecans run the risk of serious or li Mon, 14 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boston-baking-issues-allergy-alert-undeclared-pecans-boston-baking-mini-cinnamon-crumb-cakes Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin M Mon, 14 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller Big Sky Bread Company Issues Allergy Alert on Undeclared Milk in Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/big-sky-bread-company-issues-allergy-alert-undeclared-milk-chocolate-chunk-granola-and-chocolate Big Sky Bread Company of Urbandale, IA is recalling their Big Sky Chocolate Chunk Granola and Big Sky Chocolate Chunk Peanut Butter Chip Granola because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious allergic reaction if they consume Wed, 09 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/big-sky-bread-company-issues-allergy-alert-undeclared-milk-chocolate-chunk-granola-and-chocolate Seven Seas International USA, LLC Voluntarily Recalls Giant Food Private Label Wild Caught Alaskan Sockeye Smoked Salmon Because of Possible Health Risk http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalls-giant-food-private-label-wild-caught-alaskan Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 540 cases of Giant Food Private Label Sockeye Smoked Salmon, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young Tue, 08 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalls-giant-food-private-label-wild-caught-alaskan Comercializadora PepsiCo S. de R.L. de C.V. Issues Voluntary Recall of Gamesa® Arcoiris Marshmallow Cookies Due to Possible Health Risk http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercializadora-pepsico-s-de-rl-de-cv-issues-voluntary-recall-gamesar-arcoiris-marshmallow-cookies Comercializadora PepsiCo S. de R.L. de C.V. today issued a voluntary recall for 15.5 oz, 6 count box of Gamesa Arcoiris Marshmallow Cookies due to the potential presence of Salmonella. Mon, 07 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercializadora-pepsico-s-de-rl-de-cv-issues-voluntary-recall-gamesar-arcoiris-marshmallow-cookies Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adams-polishes-llc-issues-voluntary-nationwide-recall-hand-sanitizer-due-potential-contamination Thornton, Colorado, Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer to the consumer level. FDA testing has found this lot to contain undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. Persons who accidently ingest ( Sat, 05 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adams-polishes-llc-issues-voluntary-nationwide-recall-hand-sanitizer-due-potential-contamination Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022 http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issued-voluntary-medical-device-correction-omnipod-dashr-personal-diabetes-manager-october Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Fri, 04 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issued-voluntary-medical-device-correction-omnipod-dashr-personal-diabetes-manager-october Kalera Voluntarily Recalls Fresh Lettuce Products Because of Possible Health Risk http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kalera-voluntarily-recalls-fresh-lettuce-products-because-possible-health-risk Kalera Public Limited Company (“Kalera” or the “Company”) (Nasdaq: KAL), is voluntarily recalling 633 cases of Krunch, Butter and Romaine whole head variety lettuce with lot codes 001293 and 001294 on the label and sold under the Kalera brand because it has the potential to be contaminated with Salm Thu, 03 Nov 2022 13:02:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kalera-voluntarily-recalls-fresh-lettuce-products-because-possible-health-risk Nestlé USA Announces Voluntary Recall of Limited Quantity of Edible Chocolate Chip Cookie Dough Tubs from NESTLÉ® TOLL HOUSE® Due to Potential Presence of Foreign Material http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-limited-quantity-edible-chocolate-chip-cookie-dough-tubs Nestlé USA is initiating a voluntary recall of a limited quantity of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® due to the potential presence of soft plastic film. This voluntary recall is isolated to three batches of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HO Thu, 03 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-limited-quantity-edible-chocolate-chip-cookie-dough-tubs Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teleflex-announces-worldwide-recall-gibeckr-iso-gardr-filter Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for Thu, 03 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teleflex-announces-worldwide-recall-gibeckr-iso-gardr-filter Issue With “Gluten Free” Labeling on Cedar Creek Popcorn Box Containing Gluten http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/issue-gluten-free-labeling-cedar-creek-popcorn-box-containing-gluten Cedar Creek Popcorn of Sac City, Iowa is recalling its 18 oz. Old-Fashioned Caramel Holiday Popcorn Box because the side of the box features a Gluten Free claim when there are elements with gluten contained in the product. People who have an allergy or severe sensitivity to wheat run the risk of s Fri, 28 Oct 2022 17:18:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/issue-gluten-free-labeling-cedar-creek-popcorn-box-containing-gluten Daiso Issues Allergy Alert on Tiramisu Twist Cookies Almonds and Hazelnuts Not Identified as Ingredients on Packaging http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-tiramisu-twist-cookies-almonds-and-hazelnuts-not-identified-ingredients Daiso California LLC of La Mirada, CA is recalling its Tiramisu Twist Cookies (sku 4562138450820) because the product contains almonds and hazelnuts, ingredients that are not identified on the packaging Thu, 27 Oct 2022 12:37:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-tiramisu-twist-cookies-almonds-and-hazelnuts-not-identified-ingredients Whole Foods Market Issues Allergy Alert for Dipping Caramel Sold in Five Stores in Colorado, Kansas and Nebraska http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-dipping-caramel-sold-five-stores-colorado-kansas-and Whole Foods Market is voluntarily recalling Dipping Caramel from five stores in Colorado, Kansas, and Nebraska because the product may contain wheat, which is not declared on the product label. People who have an allergy or severe sensitivity to wheat should not consume this product because they run Thu, 27 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-dipping-caramel-sold-five-stores-colorado-kansas-and