FDA recalls, November 2023: 226 published

82 different companies appear this month.

Risk classification: Class I: 129 · Class II: 77 · Class III: 20

Same month, other agencies:CPSC 35 recallsFSIS 5 recallsNHTSA 85 recalls

Recalls this month

DateProduct
November 29, 2023Medline manual resuscitators with integrated manometer, multiple accessory configurations…Z-0369-2024SunMed Holdings, LLC
November 29, 2023ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, E…F-0463-2024ActiPharma, Inc.
November 29, 2023Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vi…D-0117-2024Exela Pharma Sciences LLC
November 29, 2023ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Do…D-0118-2024Exela Pharma Sciences LLC
November 29, 2023Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract…Z-0342-2024Aizu Olympus Co., Ltd.
November 29, 2023Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple acce…Z-0361-2024SunMed Holdings, LLC
November 29, 2023HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8.25oz, UPC 004122025365 Giant…F-0462-2024Treehouse Foods
November 29, 2023Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pin…F-0465-2024Jeni's Splendid Ice Creams LLC
November 29, 2023Tracheal fiberscope-airway management, which includes observation to access airway anatom…Z-0338-2024Aizu Olympus Co., Ltd.
November 29, 2023LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL)…D-0133-2024Cardinal Health Inc.
November 29, 2023Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful o…Z-0375-2024Biomet, Inc.
November 29, 2023Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endos…Z-0333-2024Aizu Olympus Co., Ltd.
November 29, 20238.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose V…D-0116-2024Exela Pharma Sciences LLC
November 29, 2023LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bot…D-0136-2024Cardinal Health Inc.
November 29, 2023LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) droppe…D-0132-2024Cardinal Health Inc.
November 29, 2023Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15m…D-0108-2024The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
November 29, 2023Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b)…D-0114-2024NCS Healthcare of Kentucky Inc
November 29, 2023Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topi…D-0110-2024Integrity Bio-Chemicals LLC
November 29, 2023EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242…Z-0396-2024Boston Scientific Corporation
November 29, 2023Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topica…D-0109-2024Integrity Bio-Chemicals LLC
November 29, 2023Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist.…D-0107-2024The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
November 29, 2023Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-77…D-0113-2024NCS Healthcare of Kentucky Inc
November 29, 2023LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL…D-0134-2024Cardinal Health Inc.
November 29, 2023GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024…Z-0358-2024Instrumentation Laboratory
November 29, 2023Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteo…Z-0388-2024Biomet, Inc.
November 29, 2023Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topi…D-0111-2024Integrity Bio-Chemicals LLC
November 29, 2023Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL eac…D-0115-2024ITF PHARMA INC
November 29, 2023LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 …D-0135-2024Cardinal Health Inc.
November 29, 2023Asenzya Hot & Spicy Cajun Style Seasoning, Item 121331. Net Wt 15 lbs. Distributed by: …F-0464-2024Asenzya Inc.
November 29, 2023stryker Sage PrimaFit External Urine Management System for the Female AnatomyZ-0356-2024Sage Products Inc
November 29, 2023Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful o…Z-0374-2024Biomet, Inc.
November 29, 2023LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoli…D-0131-2024Cardinal Health Inc.
November 29, 2023Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottl…D-0112-2024Glenmark Pharmaceuticals Inc., USA
November 22, 2023GUAVA JELLY, Ice-cream base, natural flavoring, artificial coloring. PARADISE FLAVORS. 4 …F-0425-2024Paradise Flavors LLC
November 22, 2023Avocado, ice-cream base, Natural flavor, artificial coloring. DISTRIBUTED BY PARADISE FLA…F-0454-2024Paradise Flavors LLC
November 22, 2023Full Spectrum Cold Pressed Hemp Oil Gummies, Pomegranate, 1.41 oz (4-count) and 8oz (15-…F-0417-2024Tay's Sales and Distribution
November 22, 2023BANANA BREAD , Ice-cream base, Natural fruit, bread, dehydrated fruit. PARADISE FLAVORS L…F-0435-2024Paradise Flavors LLC
November 22, 2023MAGNUM, ice-cream base, natural flavoring, 4 OZ. DISTRIBUTED BY PARADISE FLAVORS LLC. Pac…F-0451-2024Paradise Flavors LLC
November 22, 2023RUM RAISIN, ice-cream base, artificial flavoring natural fruits, artificial. DISTRIBUTED …F-0433-2024Paradise Flavors LLC
November 22, 2023BUTTER PECAN, Ice-cream base, Natural flavor, graham crackers, artificial color, citric a…F-0427-2024Paradise Flavors LLC
November 22, 2023EZQUIMAL, ice-cream base, natural flavoring, chocolate cover, penuts. 4 OZ. DISTRIBUTED B…F-0452-2024Paradise Flavors LLC
November 22, 2023Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel, 1.41 oz (4-count) and 8oz (15-count).F-0418-2024Tay's Sales and Distribution
November 22, 2023YOGOBERRY (YOGURT WITH FRUITS), Ice cream, Mix Berries, Granola, Honey, Citric acid., PA…F-0441-2024Paradise Flavors LLC
November 22, 2023FLORIDA SUNRISE/CHEMIS, Paradise Flavors LLC, Ice-cream base, natural flavoring, artifici…F-0442-2024Paradise Flavors LLC
November 22, 2023UNICORN Ice-cream base, natural flavors, Artificial Flavoring, Artificial color. DISTRIBU…F-0423-2024Paradise Flavors LLC
November 22, 2023MAMEY with sweet and condensed milk, PARADISE FLAVORS, 4 OZ. Packaged in plastic pouch. …F-0450-2024Paradise Flavors LLC
November 22, 2023BLUM'S SHRIMP SHRED DRIED SHRIMP, COOKED IN SALT WATER, BLUM'S SEAFOOD PRODUCTS LLC, Net …F-0413-2024EL Chilar-HF, LLC
November 22, 2023Pina Colada, ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4…F-0431-2024Paradise Flavors LLC
November 22, 2023Strawberries and Cream, ice-cream base, natural flavoring. Paradise Flavors LLC. 4 oz. Pa…F-0432-2024Paradise Flavors LLC
November 22, 2023BUBBLEGUM GUMMYBEAR, ice-cream base, artificial flavor. Distributed by: PARADISE FLAVORS …F-0460-2024Paradise Flavors LLC

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