FDA recalls, December 2024: 455 published

129 different companies appear this month.

Risk classification: Class I: 44 · Class II: 404 · Class III: 7

Same month, other agencies:FSIS 5 recallsNHTSA 80 recalls

Recalls this month

DateProduct
December 11, 2024Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pu…D-0104-2025AvKARE
December 11, 2024PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakM…D-0084-2025Boulla LLC
December 11, 2024Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-0…D-0107-2025Rising Pharma Holding, Inc.
December 11, 2024Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured …D-0099-2025Amerisource Health Services LLC
December 11, 2024Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distribute…D-0112-2025Lannett Company Inc.
December 11, 2024ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St.…D-0086-2025Boulla LLC
December 11, 2024ENOKI MUSHROOM; 200g/package (25 packages/case); vacuum packed; refrigerated "***ENOKI M…F-0255-2025HH FRESH TRADING CORP
December 11, 2024GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT …Z-0613-2025GE Healthcare (China) Co., Ltd.
December 11, 2024ELLINGTON FARMS LEMONADE DRINK MIX NATURAL FLAVOR, Net Wt. 24 oz (1.5 lbs) 680g, UPC 0 46…F-0224-2025DYMA BRANDS
December 11, 2024BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296Z-0594-2025Becton Dickinson & Co.
December 11, 2024Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) …D-0100-2025Amerisource Health Services LLC
December 11, 2024Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray systemZ-0579-2025Orthoscan, Inc.
December 11, 2024MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO…Z-0649-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 4…Z-0592-2025Becton Dickinson & Co.
December 11, 2024BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570Z-0595-2025Becton Dickinson & Co.
December 11, 2024SYSCO VANILLA INSTANT, NET WT. 24OZ, Case UPC 10074865103791, DISTRIBUTED BY SYSCO CORPOR…F-0239-2025DYMA BRANDS
December 11, 2024Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL …D-0081-2025American Regent, Inc.
December 11, 2024THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE, NET WT. 8.6 OZ (244 g), UPC 7…F-0240-2025DYMA BRANDS
December 11, 202410 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + …D-0111-2025Generitech Corporation
December 11, 2024boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufacture…D-0088-2025Midlab Incorporated
December 11, 2024ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GAL…D-0090-2025Midlab Incorporated
December 11, 2024Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, …D-0103-2025AvKARE
December 11, 2024Fresh Express Gourmet Cafe Santa Fe Greek 5.2 oz, Labeled Salad Bowls, Refrigerate, UPC C…F-0257-2025Fresh Express Incorpated
December 11, 2024GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/com…Z-0609-2025GE Healthcare (China) Co., Ltd.
December 11, 2024MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; …Z-0642-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, …Z-0625-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024Ziehm Vision FD. Interventional fluoroscopic x-ray systemZ-0576-2025Orthoscan, Inc.
December 11, 2024GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systemsZ-0601-2025GE Healthcare (China) Co., Ltd.
December 11, 2024Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.Z-0582-2025Wilson-Cook Medical Inc.
December 11, 2024GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography syst…Z-0605-2025GE Healthcare (China) Co., Ltd.
December 11, 2024OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room TemperatureF-0221-2025Armonia Natural Store LLC
December 11, 2024Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only…D-0096-2025Glenmark Pharmaceuticals Inc., USA
December 11, 2024MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) E…Z-0631-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography systemZ-0608-2025GE Healthcare (China) Co., Ltd.
December 11, 2024MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) T…Z-0647-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC N…Z-0640-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024Ziehm Solo FD. Interventional fluoroscopic x-ray systemZ-0574-2025Orthoscan, Inc.
December 11, 2024BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385Z-0593-2025Becton Dickinson & Co.
December 11, 2024GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China O…Z-0615-2025GE Healthcare (China) Co., Ltd.
December 11, 2024Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.Z-0583-2025Philips North America Llc
December 11, 2024MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141BZ-0636-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024Gordon CHOICE Lemonade Beverage Mix Naturally Flavored Low Calorie Instant LOW CAL LEMONA…F-0226-2025DYMA BRANDS
December 11, 2024100% CIDER Pasteurized APPLE WEDGE CIDER 1 Gal. (3.78L) HENDERSONVILLE, NC 28792 Keep Ref…F-0249-2025Apple Wedge LLC
December 11, 2024VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: …D-0083-2025Boulla LLC
December 11, 2024Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by…D-0105-2025Rising Pharma Holding, Inc.
December 11, 2024SYSCO FRUIT PUNCH, NET WT. 24OZ, Case UPC 10074865093221, DISTRIBUTED BY SYSCO CORPORATIO…F-0236-2025DYMA BRANDS
December 11, 2024BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990Z-0589-2025Becton Dickinson & Co.
December 11, 2024MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS…Z-0626-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024Refer to RES or lead review memo for complete list of affected reference/catalog numbersZ-0635-2025MEDLINE INDUSTRIES, LP - Northfield
December 11, 2024Sysco Classic Banana Instant Pudding & Pie Filling Mix Natural and Artificial Flavor, NET…F-0230-2025DYMA BRANDS

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