FDA recalls, September 2025: 201 published

93 different companies appear this month.

Risk classification: Class I: 32 · Class II: 131 · Class III: 38

Same month, other agencies:CPSC 20 recallsFSIS 6 recallsNHTSA 105 recalls

Recalls this month

DateProduct
September 10, 2025Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn PharmacyD-0606-2025Boothwyn Pharmacy LLC
September 10, 2025ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC (SYSCO) Cleantail Breaded Butterfly Shri…H-0552-2025TAMPA MAID FOODS, LLC
September 10, 2025WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to …Z-2435-2025Boston Scientific Corporation
September 10, 2025Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented …Z-2522-2025ICU Medical Inc.
September 10, 2025Clean-tail Coconut Farm Raise Breaded Butterfly Shrimp Clean Tail (21/25 CT per pound) in…H-0553-2025TAMPA MAID FOODS, LLC
September 10, 20250.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., B…D-0628-2025B BRAUN MEDICAL INC
September 10, 2025Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218…Z-2519-2025Lumicell, Inc.
September 10, 2025Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn PharmacyD-0608-2025Boothwyn Pharmacy LLC
September 10, 2025Lemon Meringue Pie, 8" round. Net Wt. 27 OZ; Refrigerate after opening Item Code 31811; …H-0568-2025Jessie Lord Bakery, LLC
September 10, 2025Medshape Universal Joints, REF: DNE-9000-UJZ-2513-2025Medshape, INC.
September 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufacture…D-0616-2025Amneal Pharmaceuticals, LLC
September 10, 2025PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, …D-0613-2025DermaRite Industries, LLC
September 10, 2025Chocolate Walnut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 1…H-0560-2025The Candy Barn
September 10, 2025Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. …Z-2526-2025ICU Medical Inc.
September 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufacture…D-0619-2025Amneal Pharmaceuticals, LLC
September 10, 2025IDM-MICRO-R. Electrical wheelchair component.Z-2456-2025mo-Vis BVBA
September 10, 2025DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 1…Z-2481-2025Medtronic Perfusion Systems
September 10, 2025RayStation with the following product descriptions: 1. RayStation 9B, Software Versio…Z-2489-2025RAYSEARCH LABORATORIES AB
September 10, 2025Chocolate Pecan Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10…H-0562-2025The Candy Barn
September 10, 2025RayStation with the following product descriptions: 1. RayStation 11A, Software Versi…Z-2491-2025RAYSEARCH LABORATORIES AB
September 10, 2025Evergreen Farm Korean Pear Juice, 4 fl. oz. (120ml) , Foil pouches, 25 foil pouches per …H-0555-2025Evergreen Orchard Farm, LLC
September 10, 2025Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Pac…D-0615-2025Amneal Pharmaceuticals, LLC
September 10, 2025Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn PharmacyD-0609-2025Boothwyn Pharmacy LLC
September 10, 2025Product Name: Blueberry Pretzels " Brand Name: HEB " Description: 8oz HEB Blueberry Flavo…H-0550-2025Dollins Pecan Co, Inc
September 10, 2025English Toffee, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 5oz, packed in…H-0565-2025The Candy Barn
September 10, 2025Maple Nut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, pa…H-0564-2025The Candy Barn
September 10, 2025Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pumpZ-2333-2025Baxter Healthcare Corporation
September 10, 2025DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRit…D-0611-2025DermaRite Industries, LLC
September 10, 2025Nirwana Foods, Golden Raisin, 28 oz (794g), Net Wt. 1.75 LBS, Clear Bags, 20 bags Per Ca…H-0554-2025NIRWANA FOODS LLC
September 10, 2025Hans Kissle Red Bliss Potato SaladH-0558-2025Hans Kissle Company, LLC
September 10, 2025KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dil…D-0614-2025IMMUNOCORE, LLC
September 10, 2025Peanut Butter Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz…H-0563-2025The Candy Barn
September 10, 2025Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884…Z-2485-2025Boston Scientific Neuromodulation Corporation
September 10, 2025Evergreen Farm Grape Juice, 4 fl. oz. (120ml) , Foil pouches, 25 foil pouches per case, …H-0556-2025Evergreen Orchard Farm, LLC
September 10, 2025InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)Z-2496-2025Medtronic MiniMed, Inc.
September 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured…D-0617-2025Amneal Pharmaceuticals, LLC
September 10, 2025Chocolate Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, pa…H-0559-2025The Candy Barn
September 10, 2025Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Pro…Z-2505-2025Integra LifeSciences Corp. (NeuroSciences)
September 10, 2025chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactur…D-0618-2025Amneal Pharmaceuticals, LLC
September 10, 2025DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packa…D-0610-2025DermaRite Industries, LLC
September 3, 2025Carton Label: "Friendly's Vanilla Bean"; 48 fl. oz. Lid Label: "Friendly's Cookies and C…H-0537-2025DFA Dairy Brands, LLC
September 3, 2025L10-4LAP Transducer ProbeZ-2370-2025Philips Ultrasound, Inc
September 3, 2025Deep Sprouted Mat 16 oz.H-0574-2025CHETAK NEW YORK LLC
September 3, 2025Baker's Authority Graham Cracker Meal; 5lb bag; stored dry at room temperature; packaged …H-0535-2025Bakers Authority LLC
September 3, 2025L18-5 Transducer ProbeZ-2380-2025Philips Ultrasound, Inc
September 3, 2025Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: …D-0599-2025Lannett Company Inc.
September 3, 2025VL13-5 Transducer ProbeZ-2405-2025Philips Ultrasound, Inc
September 3, 2025AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI …Z-2468-2025American Contract Systems Inc
September 3, 2025Akreos, SKU: AO60P0300. Akreos intraocular lensesZ-2451-2025Bausch & Lomb Surgical, Inc.
September 3, 2025H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with component…D-0603-2025MEDLINE INDUSTRIES, LP - Northfield

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