FDA News

Face Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk

November 14, 2025, Face Rock Creamery LLC of Bandon, OR is voluntarily recalling 16/6oz. units of Vampire Slayer Garlic Cheddar with a use-by date of 11/04/26 because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infectio Read More (external link)...

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In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula

[New York, NY] – ByHeart, a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ong Read More (external link)...

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Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg Read More (external link)...

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Africa Imports Issues Voluntary Recall of Organic Moringa Leaf Powder Due to Potential Salmonella Contamination

Africa Imports is voluntarily recalling its Organic Moringa Leaf Powder (1 kilogram box) because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, the elderly, and individuals with weakened immune systems. Healthy persons inf Read More (external link)...

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African Food on Wheels Inc. Recalls Oven Dried Fish (Scomberomorus Cavalla) Because of Possible Health Risk

African Food on Wheels Inc. of Bronx, NY is recalling 28 boxes of Product, because it is a dried, un-eviscerated (internal organs not removed) fish greater than 5 inches and length and has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illne Read More (external link)...

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Dreyer’s Grand Ice Cream, Inc. Issues Allergy Alert on Undeclared Wheat in Haagen-Dazs Chocolate Dark Chocolate Mini Bars in 6 Count Pack

November 3, 2025, Dreyer’s Grand Ice Cream, Inc. is voluntarily recalling a limited number of its Häagen-Dazs Chocolate Dark Chocolate Mini Bars that may contain undeclared wheat. Those with an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if th Read More (external link)...

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durin Read More (external link)...

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product Read More (external link)...

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First and Last Bakery, LLC Recalls First and Last Brand Tomato Sauce Products Because Of Possible Health Risk

First and Last Bakery, LLC of Hartford, CT, is recalling the following products due to a possible health risk identified by the Connecticut Department of Consumer Protection. • First and Last Original Marinara Sauce, Tomato & Basil • First and Last Original Traditional Pasta Sauce, Meat Flavored Read More (external link)...

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Vanguard Enterprises, LLC. dba Bedrock MFG Recalls Monarch Premium Kratom Powder Because of Possible Health Risk

October 28, 2025, Vanguard Enterprises, LLC. DBA Bedrock MFG of Boise, Idaho is recalling Monarch Premium Kratom brand Bali Gold, Red Bali, Green Maeng Da, and White Elephant powder because product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometime Read More (external link)...

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Vanguard Enterprises, LLC. dba Bedrock MFG Recalls Monarch Premium Kratom Powder Because of Possible Health Risk

October 28, 2025, Vanguard Enterprises, LLC. DBA Bedrock MFG of Boise, Idaho is recalling Monarch Premium Kratom brand Bali Gold, Red Bali, Green Maeng Da, and White Elephant powder because product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometime Read More (external link)...

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Moonlight Companies Voluntarily Recalls California-Grown Conventional Yellow and White Peaches Because of Possible Health Risk

October 29, 2025 – Moonlight Companies is voluntarily recalling California-grown conventional yellow and white peaches because they have the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly Read More (external link)...

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