FDA News

Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination

02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S Read More (external link)...

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Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial

February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of Read More (external link)...

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Lyons Magnus Recalls Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes Manufactured by Third Party Because of Possible Health Risk

Lyons Magnus LLC (“Lyons Magnus”) today announced that it is voluntarily recalling 4 oz. Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes due to the potential for the products to be contaminated with Listeria monocytogenes. Lyons Magnus is taking this action in response to a recall of t Read More (external link)...

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Kedake Inc. Issues Allergy Alert on Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6 in Botana Mix Snacks

KEDAKE, INC. of Houston, TX is recalling it’s 2 lb packages of Las Ollas Botana Mix Snacks because they may contain undeclared Sesame, Soy, Wheat, Yellow No 5, Yellow No 6, and Red No 6. People who have an allergy or severe sensitivity to Sesame, Soy, Wheat, Yellow No 5, Yellow No 6 and Red No 6, ru Read More (external link)...

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One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

Benton, Arkansas – 02/2019/2025 –One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunctio Read More (external link)...

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ZB Importing Issue Voluntary Recall and Allergy Alert on Undeclared Egg, Wheat and Milk in Certain Ulker Brand Products

ZB Importing LLC is voluntarily recalling certain lots of six varieties of Ulker Brand snack rolls, biscuits, and wafers due to undeclared wheat, egg and/or milk in the Ingredient List and/or Contains Statement on the product labels. People who have an allergy or severe sensitivity to wheat, egg, or Read More (external link)...

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Naturipe Value Added Fresh LLC Issues Allergy Alert On Undeclared Wheat & Eggs In “Berry Buddies, Berries & Pancakes” Lot # 1097901

Naturipe Value Added Fresh LLC. of Alma, GA, is recalling its 2.1 oz./60 gram packages of "Berry Buddies, Berries & Pancakes" bento box snack packs because they contain wheat and EGGS that were not declared on the label. People who have allergies to WHEAT and/or EGGS run the risk of serious allergic Read More (external link)...

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ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have inco Read More (external link)...

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Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal

Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal Read More (external link)...

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JE Bakery 2019 LLC DBA Broadway Bakery Issues Allergy Alert for Mislabeled Raisin Bran Muffin 6 Count Due to Undeclared Walnuts

JE Bakery 2019, LLC, Minneapolis MN is voluntarily recalling its Raisin Bran Muffin 6 count due to a labeling error. The affected product was mislabeled and instead contains Glorious Morning Muffins, which contains Walnuts, a known allergen not declared on the label. Read More (external link)...

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