FDA recalls: November 2023
Every food and drug recall report the FDA published in November 2023: 225 reports, 151 of them Class I.
- Recall reports
- 225
- Class I (serious)
- 151
- Food
- 166
- Drugs
- 59
- Nov 29, 2023Polyvinyl Alcohol 1Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Class I
- Nov 29, 2023Lubricating Tears Eye Drops (Dextran/Hypromellose), 0Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesNon-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Class I
- Nov 29, 2023Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topi…Drug · Integrity Bio-Chemicals LLCCGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.Class II
- Nov 29, 2023Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented To…Drug · Integrity Bio-Chemicals LLCCGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.Class II
- Nov 29, 2023Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented To…Drug · Integrity Bio-Chemicals LLCCGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.Class II
- Nov 29, 2023Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottleDrug · Glenmark Pharmaceuticals Inc., USAFailed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).Class III
- Nov 29, 2023Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-…Drug · NCS Healthcare of Kentucky IncPresence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lotsClass III
- Nov 29, 2023Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05),…Drug · NCS Healthcare of Kentucky IncPresence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lotsClass III
- Nov 29, 2023Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL e…Drug · ITF PHARMA INCFailed Viscosity Specifications: Out-of-specification test results for viscosityClass II
- Nov 29, 20238.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose…Drug · Exela Pharma Sciences LLCPresence of Particulate Matter: SiliconeClass I
- Midazolam in 0
- ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single…
- LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0
- LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%)
- LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0
- LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0
- LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0
- LEADER brand Lubricant Eye Drops (Propylene Glycol, 0
- HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8
- ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309,…
- Asenzya Hot & Spicy Cajun Style Seasoning, Item 121331
- Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard p…
- DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118…
- DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle…
- Equate Hand Sanitizer (Ethyl Alcohol 62%), 7
- Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C
- Guilt Free No Sugar Added Ice Cream Homemade Vanilla 1
- Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in fi…
- ORALE! CAMARON MOLIDO, GROUND SHRIMP
- ORALE! CAMARON NATURAL, NATURAL SHRIMP
- EL CHILAR CAMARON NATURAL, NATURAL SHRIMP
- BLUM'S SHRIMP SHRED DRIED SHRIMP, COOKED IN SALT WATER, BLUM'S SEAFOOD PRODUCTS LLC
- Full Spectrum Cold Pressed Hemp Oil Gummies, Fruit Punch, 1
- Full Spectrum Cold Pressed Hemp Oil Gummies, Blackberry, 1
- Full Spectrum Cold Pressed Hemp Oil Gummies, Peach, 1
- Full Spectrum Cold Pressed Hemp Oil Gummies, Pomegranate, 1
- Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel, 1
- Item 19858, Amazon Fresh, Frosted Mini Brownie with yellow and purple icing with sprink…
- UNICORN Ice-cream base, natural flavors, Artificial Flavoring, Artificial color
- MINT CHOCOLATE CHIP, Ice-cream base, Chocolate chips, Artificial Flavoring, Artificial…
- GUAVA JELLY, Ice-cream base, natural flavoring, artificial coloring
- VANILLA, Ice-cream base, Natural flavor, artificial flavor and coloring
- BUTTER PECAN, Ice-cream base, Natural flavor, graham crackers, artificial color, citric…
- PINK GUABA, Ice-cream mix, filtered water, Natural Flavoring, sugar, Artificial color
- CAPPUCCINO, Ice-cream base, natural flavoring, artificial flavoring
- SWEET CORN/ELOTE, Ice cream mix, natural flavoring, sea salt
- Pina Colada, ice-cream base, natural flavoring, artificial flavoring
- Strawberries and Cream, ice-cream base, natural flavoring
- RUM RAISIN, ice-cream base, artificial flavoring natural fruits, artificial
- Trail Mix/Frutas Secas, Ice-cream base, dried fruits and nuts, vanilla extract
- BANANA BREAD , Ice-cream base, Natural fruit, bread, dehydrated fruit
- Pistachio, Ice-cream base, Natural Flavors, Artificial Colors
- KEY LIME CREAMSICLE, Filtered water, ice-cream base, natural flavoring, artificial colo…
- CHOCOLATE RAZZBERRY CAKE (GANCITO)
- ARROZ CON LECHE/RICE PUDDING, Ice cream MIX, Filtered water, Natural Rice, cinamon and…
- MAMEY, PARADISE FLAVORS LLC, 4 oz
- YOGOBERRY (YOGURT WITH FRUITS), Ice cream, Mix Berries, Granola, Honey, Citric acid
- FLORIDA SUNRISE/CHEMIS, Paradise Flavors LLC, Ice-cream base, natural flavoring, artifi…
- DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring
- CHOCOLATE WITH ALMONDS, ice-cream base, chocolate powder, natural flavoring, PARADISE F…
- Ferrero Rocher, Ice-cream base, Hazelnut, Nutella, Penuts, Cacao, Rich Chocolate, Artif…
- BLACKBERRY CHEESECAKE, Ice-cream base, Natural Flavor, Cheese, Butter, crackers
- Pine Nut/Pinon, Ice Cream Bar, Ice cream base, natural flavoring, dehydrated fruit, art…
- PEANUT BUTTER/MAZAPAN, Ice-cream base, Natural Flavor, Artificial Color, sea salt
- Cookies And Cream, distributed by Paradise Flavors LLC, 4 OZ, 120ML, Packaged in plasti…
- MAMEY with sweet and condensed milk, PARADISE FLAVORS, 4 OZ
- MAGNUM, ice-cream base, natural flavoring, 4 OZ
- EZQUIMAL, ice-cream base, natural flavoring, chocolate cover, penuts
- CHOCOLATE, ice-cream base, chocolate powder, natural flavoring,
- Avocado, ice-cream base, Natural flavor, artificial coloring
- COCONUT/COCO ice cream mix, natural flavors, artificial flavors
- KEY LIME PIE, PARADISE FLAVORS, 9601 Overseas Hwy, Marathon FL
- CHUNKY MANGO, ice-cream base, natural flavoring, artificial flavor and color
- GUANAVANA (SOURSOP/GUANABANA), ice-cream base, natural flavoring
- ORANGE CREAMCYCLE, Filtered water, natural flavoring, artificial color, citric acid and…
- BUBBLEGUM GUMMYBEAR, ice-cream base, artificial flavor
- Cotton Candy with M&Ms, ice-cream base, M&M's, artificial flavor, food coloring
- Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr
- Buprenorphine HCl, Injection, 0
- Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0
- Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd
- Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amnea…
- Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: M…
- Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured…
- Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufacture…
- Oxaydo (oxycodone HCl, USP) tablets, 7
- Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured…
- Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manu…
- Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Man…
- Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Man…
- V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutri…
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of…
- 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe,…
- 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe…
- Hinterland Dairy Farmstead Cheese Happy Jack Monterey Jack Cheese, packaged in bulk and…
- Hinterland Dairy Farmstead Cheese Mango Habanero, a jack-style cheese, packaged in 8oz…
- Hinterland Dairy Farmstead Cheese Jalapeno Happy Jack Monterey Jack, packaged in bulk a…
- Hinterland Dairy Farmstead Cheese French Onion + Chive, a jack-style cheese, packaged i…
- Qilu Enterprises brand enoki mushrooms packaged in a 7
- Kula Can Pin¿a Colada + KRATOM SELTZER, 12 oz (355ML) DIETARY SUPPLEMENT
- Frozen and fresh RTE Lobster meat (1 lb
- HEB Kale Greens
- HEB Kale Greens, Net Wt
- Little Bear Fresh Kale
- Edible Cookie Dough Chocolate Chip packaged in 6 oz plastic cups lot # 3240
- Similac Probiotic Tri-Blend - 0
- Gills Onions 3 lb
- Gills Onions 8 oz cups, diced yellow onions
- Gills Onions 8 oz cups, diced celery & onions
- Gills Onions 10 oz cups, diced mirepoix
- Gills Onions 8 oz cups, diced red onions
- Cross Valley Farms 1/5LB CTN FRESH 1/4" DICED RED ONIONS W/ZIP
- Cross Valley Farms 2/5 LB CTN FRESH 1/4" DICED RED ONION W/ZIP
- Cross Valley Farms 2/5 LB CTN FRESH 3/8" DICED RED ONIONS W/ZIPPER
- Cross Valley Farms 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
- Cross Valley Farms 4/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
- Cross Valley Farms 1/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
- Cross Valley Farms 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
- Cross Valley Farms 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
- Cross Valley Farms 2/5 LB CTN FRESH 3/8" DICED YELLOW ONIONS W/ZIP
- Cross Valley Farms 4/5 LB CTN FRESH 3/8" DICED YELLOW ONIONS W/ ZIP
- Cross Valley Farms 4/5 LB CTN FRESH 1/4" SLIVERED YELLOW ONIONS W/ZIPPER
- Cross Valley Farms 2/5 LB CTN FRESH 1/8" SLIVERED YELLOW ONIONS W/ZIPPER
- Cross Valley Farms 4/5 LB CTN FRESH 1/8" SLIVERED YELLOW ONIONS W/ZIPPER
- Gills Onions 1/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
- Gills Onions 4/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
- Gills Onions 2/5 LB CTN FRESH 3/8" DICED RED ONIONS WITH ZIPPER
- Gills Onions 4/5 LB CTN FRESH 3/8" DICED RED ONIONS WITH ZIPPER
- Gills Onions 2/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIPPER
- Gills Onions 4/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIPPER
- Gills Onions 1/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
- Gills Onions 4/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIPPER
- Gills Onions 1/5 LB CTN FRESH 1/4" DICED YELLOW ONION W/ZIPPERS
- Gills Onions 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
- Gills Onions 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
- Gills Onions 2/5 LB CTN FRESH 3/8" DICED YELLOW ONION W/ZIPPER
- Gills Onions 4/5 LB CTN FRESH 3/8" DICED YELLOW ONIONS W/ZIPPER
- Gills Onions 2/5 LB CTN FRESH 1/4" SLIVERED YELLOW ONIONS W/ZIPPER
- Gills Onions 4/5 LB CTN FRESH 1/4" SLIVERED YELLOW ONIONS W/ZIPPER
- Gills Onions 2/5 LB CTN FRESH 1/8" SLIVERED YELLOW ONIONS W/ZIPPER
- 4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIPPER DARDEN
- Imperial Fresh 1/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER SYSCO
- Imperial Fresh 2/5 LB CTN FRSH 1/4" DICED RED ONIONS W/ZIPPER SYSCO 3295219
- Imperial Fresh 4/5 LB CTN FRESH 1/4" DICED RED W/ZIPPER SYSCO 4705317
- Imperial Fresh 2/5 LB CTN FRSH 3/8" DICED RED ONIONS W/ZIPPER
- Imperial Fresh 1/5 LB CTN FRSH 1/4" SLVRD RED ONIONS W/ZIPPER
- Imperial Fresh 2/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIPPER
- Imperial Fresh 4/5 LB CTN FRESH 1/8" SLIVERED RED ONIONS W/ZIP
- Imperial Fresh 2/5 LB CTN FRESH 3/16" SLVERED RED ONIONS SYSCO
- Imperial Fresh 2/5 LB CTN FRESH 1/2" DICED YLW ONIONS W/ZIP
- Imperial Fresh 4/5 LB CTN FRESH 1/2" DICED YLW ONIONS W/ZIP
- Imperial Fresh 1/5 LB CTN FRSH 1/4" DICED YLW ONIONS W/ZIP
- Imperial Fresh 2/5 LB CTN FRSH 1/4" DICED YLW ONIONS W/ZIP
- Imperial Fresh 4/5 LB CTN FRSH 1/4" DICED YLW ONIONS W/ZIP
- Imperial Fresh 1/5 LB CTN FRSH 3/8" DICED YLW ONIONS W/ ZIP
- Imperial Fresh 2/5 LB CTN FRSH 3/8" DICED YLW ONION W/ZIP
- Imperial Fresh4/5 LB CTN FRSH 3/8" DICED YLW ONIONS W/ZIP
- Imperial Fresh 2/5 LB CTN FRESH 1/4" SLIVERED YLW ONIONS W/ZIP
- Imperial Fresh 4/5 LB CTN FRESH 1/4" SLIVERED YLW ONIONS W/ZIP
- Imperial Fresh 2/5 LB CTN FRESH 1/8" SLIVERED YLW ONIONS W/ZIP
- Imperial Fresh 4/5LB CTN FRESH 1/8" SLIVERED YLW ONIONS W/ZIP
- Imperial Fresh 2/5LB CTN FRESH 3/16" SLIVERED YLW ONIONS W/ZIP
- Imperial Fresh 4/5LB CTN FRESH 3/16" SLIVERED YLW ONIONS W/ZIP
- PEAK 2/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIP
- PEAK 4/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
- PEAK 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
- PEAK 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
- PEAK 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
- PEAK 2/5 LB CTN FRESH 3/8" DICED YELLOW ONIONS W/ZIPPER
- PEAK 4/5 LB CTN FRESH 3/8" DICED YELLOW ONIONS W/ZIPPER
- Ready Set Serve 2/5LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
- Ready Set Serve 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIPPER
- Ready Set Serve 4/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
- Ready Set Serve 2/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIP
- Ready Set Serve 4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIP
- Ready Set Serve 4/5 LB CTN FRESH 3/8" DICED YELLOW ONIONS W/ZIPPER
- Ready Set Serve 2/5 LB CTN FRESH 1/4" SLIVERED YELLOW ONIONS W/ZIPPER
- Ready Set Serve 2/5 LB CTN FRESH 3/16" W/SLICE "G" CUT YLW W/ZIPPER
- Ready Set Serve 2/5LB CTN FRESH 3/16" STRIP SLIVERED "G" W/ZIPPER
- WANABANA APPLE CINNAMON FRUIT PUREE
- Weis CINNAMON APPLE SAUCE
- Schnucks APPLE SAUCE FRUIT POUCH, CINNAMON Net Weight: 3
- The Sausage Maker Instacure #1
- Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper as…
- Stewarts Chocolate Chip Cookies
- Mini Fruit Jelly Cups
- Mini Fruit Jelly Cups
- Mini Fruit Jelly Cups
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-co…
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packa…
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets,…
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets,…
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets,…
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets,…
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets,…
- Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4…
- Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%
- Strong Iodine Solution U
- Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Su…
- Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: S…
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6
- FreshPoint Bix Produce Company, Cantaloupe
- Favorite Day Bakery demi French bread
- Fine Sconehenge Baking Company, Chocolate Chip Scone, individually sealed plastic bag
- Fine Sconehenge Baking Company, CRANBERRY ORANGE SCONE, individually sealed plastic bag
- Fine Sconehenge Baking Company, Lemon Blueberry Scone, individually sealed plastic bag
- Fine Sconehenge Baking Company, Lemon Raspberry Scone, individually sealed plastic bag
- Fine Sconehenge Baking Company, ENGLISH SCONE, individually sealed plastic bag
- Wegman's Organics Sweet Kale Chopped Salad Kit, 8oz
- JayRobb Vanilla Flavored Egg White Protein Powder
- Crush Orange Soda, 24 Pack
- Nature's Path Organic Pumpkin Spice Waffles, 7 oz
- Nature's Path Organic Dark Chocolate Chip Waffles, 7 oz
- Methotrexate Tablets, USP, 2
- ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
- ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligen…
- Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
- Oxytocin synthetic, 30 Units added to 0
- VANCOmycin HCI PF, 1
- VANCOmycin HCI PF, 1
- Whole cantaloupe, Brand name Kandy 11 count carton, 8 count carton, 9 count carton, 15…
- Kroger Collard Greens packaged in plastic 16oz bag - 8 bags per case
- Stabilyze Sugar Stable Dark Chocolate Peanut Butter, 50g (1
- Organic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavor
- Penzeys Brady Street Cheese Sprinkle
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