FDA recalls: August 2025
Every food and drug recall report the FDA published in August 2025: 247 reports, 70 of them Class I.
- Recall reports
- 247
- Class I (serious)
- 70
- Food
- 198
- Drugs
- 49
- Aug 27, 2025BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0Drug · Taizhou Kangping Medical Science And Technology Co., Ltd.Lack of Assurance of Sterility.Class II
- Aug 27, 2025Vial Label: Epinephrine Injection, USP, 1mg/10mL (0Drug · PFIZER INCLack of Assurance of Sterility.Class II
- Aug 27, 2025Vial Label: 8Drug · PFIZER INCLack of Assurance of Sterility.Class II
- Aug 27, 2025Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0Drug · Haleon US Holdings LLCLabeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer cartonClass III
- Aug 27, 2025Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered InhalationsDrug · Cipla USA, Inc.Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.Class III
- Aug 27, 2025Carvedilol Tablets USP, 12Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppmClass II
- Aug 27, 2025Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only,…Drug · VIONA PHARMACEUTICALS INCDiscolorationClass II
- Aug 27, 2025Product is distributed in 10lb bulk packagingFood · Kobayashi Noodle U.S.A.Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.Class II
- Aug 27, 2025Product is distributed in 10lb bulk packagingFood · Kobayashi Noodle U.S.A.Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.Class II
- Aug 27, 20257up Zero Sugar Tropical Soda, 12 FL OZ (355 mL) aluminum cans, packaged in 12 pack card…Food · Buffalo Rock Company IncProduct mislabeled - cans are labeled as Zero Sugar, but contain full sugar productClass II
- Sri Sri Tattva, Ojasvita Chocomalt,7oz / 200g, Paper Pouch, 25 packages per case
- Fresh Apple Bread Net Wt 23 oz (652g) CONTAINS: MILK, SOY, & WHEAT HILLSIDE ORCHARD FAR…
- Apple Fritter Contains: Wheat, Soy and Milk Made By: Hillside Orchard Farms 105 Mitcham…
- Banana Nut Bread Net
- Fresh Blackberry Bread Net Wt
- Blueberry Bread Net Wt
- Blueberry Fritter Net Wt 7 oz (198g) CONTAINS: MILK, SOY, WHEAT
- Cheese Bread Net Wt
- Cinnamon Pecan Bread Net Wt
- Cinnamon Pecan Fritters Net Weight 7 oz (198g) CONTIANS: Wheat, Soybeans, Milk & Pecans…
- Jalapeno Cheese Bread Net Wt
- Fresh Peach Bread Net Wt
- Peach Fritter Net Weight 7 oz (198g) CONTAINS: Wheat, Soybeans, & Milk
- Strawberry Bread Net Wt
- Strawberry Fritter Net Wt 7oz (198g) CONTAINS: Wheat, Soybeans, Milk
- Product is Frozen Half Shell Oysters in 15 pound blacks
- Product is Frozen Half Shell Oysters in 15 pound blacks
- BISCUIT MIX, SNG 1000042143 NET WEIGHT 2
- Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distrib…
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Man…
- Carvedilol Tablets, USP, 3
- Carvedilol Tablets, USP, 12
- Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Ph…
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Ma…
- Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata…
- Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renat…
- Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by…
- Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Bli…
- Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonp…
- 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, n…
- Carvedilol Tablets, USP, 12
- Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenm…
- Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz
- a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actyl…
- Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC
- Lithium Orotate, 2
- Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC
- Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC
- Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC
- Lithium Orotate 2
- Lithium Orotate, Weyland Brain Nutrition
- Sukhi's CLASSIC CURRY PASTE
- Sukhi's TIKKA MASALA CURRY PASTE
- Sukhi's, CLASSIC CURRY INDIAN CURRY SAUCE
- Sukhi's, TIKKA MASALA INDIAN CURRY SAUCE
- Soda Biscuit (Rye Flavor)
- Soda Biscuit (Sea Salt Fresh Milk Flavor)
- Soda Biscuit (Quinoa Chia Seed Flavor)
- Product is distributed in bulk brown paper bags
- La Michoacana Coconut Con Crema Single Serve Paleta 3
- La Michoacana Strawberry Con Crema Single Serve Paleta 3
- La Michoacana Mango Con Crema Single Serve Paleta 3
- La Michoacana Bubble Gum Single Serve Paleta 3
- La Michoacana Cookies N Cream Single Serve Paleta 3
- La Michoacana Coconut Con Crema 6-Pack Paleta 16
- La Michoacana Strawberry Con Crema 6-Pack Paleta 16
- La Michoacana Minis Variety Paletas 12-Count 16
- La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
- La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
- Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
- Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
- Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
- Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UP…
- Jewel Osco CLUB SANDWICHES WITH SALAD
- READY MEALS DUO TUNA SALAD W/ CRACKERS
- READY MEALS QUAD TUNA SALAD
- READY MEALS TUNA SALAD
- READY MEALS SUSTAINABLE TUNA SALAD CROISSANT SANDWICH
- Jewel Osco TUNA SALAD
- READY MEALS PREMIUM TUNA SALAD
- READY MEALS TUNA SALAD SNACKER TRAY
- READY MEALS TUNA SALAD CROISSANT SANDWICH
- READY MEALS TUNA SALAD OVER BED OF LETTUCE
- Randalls PREMIUM TUNA SALAD
- Randalls MINI SALAD CROISSANT 16 INCH TRAY
- Randalls MINI SALAD CROISSANT 18 INCH TRAY
- Randalls SALAD SANDWICH 12 INCH TRAY
- Randalls SALAD SANDWICH 16 INCH TRAY
- Whole Grain Par Baked Jalapeno Cheddar Bagel --- Ingredient Declaration: Whole White Wh…
- Whole Wheat Chocolate Croissants --- Ingredients: Whole White Wheat Flour, Enriched Whe…
- Wheat Hamburger Buns --- Ingredient Declaration: Water, Whole Wheat Flour, Enriched Whe…
- Cheddar Bagel --- Ingredient Declaration: Harvest King Flour, All purpose flour, kosher…
- Chocolate Croissants --- Ingredients: HARVEST KING FLOUR, Butter, Water, Sugar, Yeast,…
- FG60005 Blueberry Basil Lemonade
- FG60002 Cucumber Mint Lemonade - point of service product
- FG60007 Green Reviver Juice - point of service product
- Reduced Sodium Roast Beef Rub (Serv-Rite) NET WT: 50 lb UPC (QST# 6313)
- BBQ Riblet Seasoning (Cargill Meat)(PPM) NET WT: 50 lb UPC (QST# 5275)
- Lemon Pepper Seasoning (Tarantino) NET WT: 50 lb UPC (QST# 6402)
- Cajun Seasoning (Taratino) NET WT: 50 lb Usage: 13
- Clover Valley Instant Coffee
- Frozen Oyster Meat (IQF), Cert No
- Frozen Oyster Meat (IQF), Cert No
- Quesito El Establo brand Spanish Cheese QUESITO COLOMBIANO
- Signature Cafe Premium Tuna Salad
- Reser's Tuna Salad
- Reser's Gourmet Tuna Salad
- Sysco Imperial Deluxe Tuna Salad, Reorder #6526826
- Sysco Classic Tuna Salad, Reorder #6724249
- Reser's Tuna Salad
- Molly's Kitchens Tuna Salad, item 794599
- Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr
- Semaglutide + Cyanocobalamin 0
- Tirzepatide + Niacinamide 2
- Tirzepatide + Niacinamide 4
- Tirzepatide + Niacinamide 6
- Tirzepatide + Niacinamide 8
- Tirzepatide + Niacinamide 11
- Tirzepatide + Niacinamide 13
- Tirzepatide + Niacinamide 16
- Semaglutide + Cyanocobalamin 0
- Semaglutide + Cyanocobalamin 0
- Semaglutide +Cyanocobalamin 1
- Semaglutide + Cyanocobalamin injection solution, 2
- Semaglutide + Cyanocobalamin 2
- Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Ale…
- Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Di…
- Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-…
- Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, Sou…
- Xolair (omalizumab injection), 75 mg/0
- RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmac…
- Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg
- FANCY MEDIUM PECAN PIECES 81124 561958 554707 6/13/2025 SDC1645 90 FANCY MEDIUM PECAN P…
- Brand Name: Queen Bee Gardens Whipped Honey Raspberry
- Brand Name: Queen Bee Gardens Whipped Honey Pure
- Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Intended use: spread
- Favorite Day Bakery Frosted Sugar Cookies, 10 count
- 1) OH MMB Human Donor Milk, 20
- Parashore Pear Slices in Juice, 15 oz
- Boar's Head Chevre Goat Cheese Cranberry Cinnamon
- BREADED JALAPENO MAC & CHEESE BITES Mac & Cheese Bites
- ARAL FISH
- MEDITERRANEAN MIX COOKIES, Cesarina Cookies
- SESAME SEED COOKIES Cesarina Cookies
- Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0
- Checkers Famous Seasoned Fries
- Chobani Flip Cookie Dough Greek Yogurt
- Chobani Vanilla Greek Yogurt, 4 OZ (113g), packaged in a plastic cup
- Clover Valley Shredded Parmesan Cheese
- Clover Valley One Dozen Grade A Eggs Large, 12 ct, packaged in styrofoam
- Clover Valley 1% Low Fat Chocolate Milk, 1/2 GAL (1
- 1) Clover Valley 2% Reduced Fat Milk, 1 GAL (3
- Clover Valley Lactose Free 2% Reduced Fat Milk, 64 FL OZ (2 QTS) 1
- 1) Clover Valley Vitamin D Whole Milk, 1 GAL (3
- Imperial 48% Vegetable Oil Spread Margarine Sticks
- Milo's Lemonade, 128 FL OZ (1 GAL) 3
- Milo's Extra Sweet Tea, 128 FL OZ (1 GAL) 3
- Milo's Famous Sweet Tea, 128 FL OZ (1 GAL) 3
- Minute Maid Fruit Punch, 59 FL OZ (1
- Minute Maid Tropical Punch, 59 FL OZ (1
- Pillsbury Cinnamon Rolls Original Icing, 8 ct
- Shamrock Farms Chocolate Rockin' Protein Builder Protein Shake, 12 FL OZ (354 ML), pack…
- Shamrock Farms Whole Milk, 12 FL OZ (354 ML), packaged in a plastic bottle
- Silk Vanilla AlmondMilk, 64 FL OZ (2 QT) 1
- 1) Simply Orange Pulp Free Orange Juice, 46 FL OZ (1
- Twister Fruit Punch, 59 FL OZ (1
- Velveeta Slices Sharp Cheddar, 16 ct
- Yoplait Original Harvest Peach Yogurt, 6 OZ (170g), packaged in a plastic cup
- Yoplait Original Strawberry Banana Yogurt, 6 OZ (170g), packaged in a plastic cup
- Item #1071 Italian layer cake
- Item #1312 Carrot layer cake
- Item #99272 Tres Leches Cheesecake
- Item #3145 Hummingbird Layer Cake
- Item #99273 chocolate Tres Leches Cheesecake
- Item #2485 Assorted layer cake
- Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers net wt 5
- Amlodipine and Benazepril HCl Capsules USP 2
- Timolol Maleate Ophthalmic Solution USP, 0
- Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL,…
- Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL,…
- Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Sc…
- Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and…
- Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hi…
- Sheehan Brothers Vending Cheeseburger, 4
- Sheehan Brothers Vending Spicy Chicken Sandwich, 6
- Sheehan Brothers Vending Italian Mini Sub, 6
- Sheehan Brothers Vending Pepperoni Pizza Mini Sub, 4
- Sheehan Brothers Vending Chili Cheese Coney, 4
- Sheehan Brothers Vending BBQ Riblet Sandwich with Coleslaw, 8 oz (226g), in a plastic t…
- Suspiros Tres Leches Cajeta Cake
- Suspiros Cajeta Cake
- Suspiros Mazapan Cake
- Suspiros 4 Leches Cake
- Suspiros Choconut Cake
- Suspiros Chocoflan Cake
- Suspiros Cheese Cake Coyota
- Suspiros German Cake
- Cajeta cupcakes (Box)
- Drycapot cookie
- Lespoir cookie
- Casa Mamita, Churro Bites Filled with Chocolate Hazelnut Cream, 7
- Fresh Chilean Salmon Fillet
- Fresh Scottish Salmon Fillet
- Blue Fin Tuna
- Yellow Fin Tuna
- NH EUROPEAN STYLE BUTTER BLEND, BUNGE
- Reisman's Jumbo Colored Sprinkles Cookies 3 oz
- Reisman's Jumbo Chocolate Chip Cookies 3 oz
- Reisman's Jumbo Black & White Cookies 3 oz
- Reisman's Jumbo Pink & White Cookies 3 oz
- Reisman's Brownie Bars 3 oz
- Reisman's Fudge Bars 3 oz
- Reisman's Cappuccino Bars 3 oz
- Reisman's Strawberry Bars 3 oz
- Reisman's Chocolate Croissants 3 oz
- Reisman's Cinnamon Croissants 3 oz
- Reisman's Vanilla Croissants 3 oz
- Reisman's Chocolate Snack 3 oz
- Reisman's Chocolate Danishes 3 oz
- Reisman's Cinnamon Danishes 3 oz
- Reisman's Vanilla Danish 3 oz
- Reisman's Chocolate Wrap 3 oz
- Reisman's Cinnamon Wrap 3 oz
- Reisman's Vanilla Wrap 3 oz
- Reisman's Chocolate Flaky Wrap 3 oz
- Reisman's Raspberry Flaky Wrap 3 oz
- Reisman's 2/pk Soft Chip Cookie (with fudge filling) 3 oz
- Reisman's Chocolate Babka Slices 3 oz
- Reisman's Cinnamon Babka Slices 3 oz
- Reisman's Candy Blast Brownie Snack 3 oz
- Organic Pure Stevia
- Pure Monk Fruit Sweetener
- Newly Weds A60447-PANKO JAPANESE STYLE UNTOASTED BREAD CRUMBS-NET WT 25 LBS
- Newly Weds A60647- BREAD CRUMBS X1-NET WT 35 LBS
- Newly Weds A93060 BREADER X1- NEW WT 40 LBS
- Newly Weds B57569 BREADER X1- NEW WT 25 LBS
- Newly Weds B6010J BREAD CRUMBS-NET WT 35 LBS
- Newly Weds B6047J-BREAD CRUMBS-NET WT 35 LBS
- Newly Weds B60960-BREAD CRUMBS X1-NET WT 6 LBS
- Newly Weds B61453-BREAD CRUMBS X1-NET WT 25 LBS
- Newly Weds B61610-BREAD CRUMBS X1-NET WT 45 LBS
- Newly Weds B61672--BREAD CRUMBS X1-NET WT 35 LBS
- Newly Weds B62262-BREAD CRUMBS X1-NET WT 1200 LBS
- Newly Weds B6229J-PIZZA CRISP-NET WT 35LBS
- Newly Weds B6AAK3-BREAD CRUMBS X1-NET WT 35LBS
- Newly Weds B90737-BREADER X1-NET WT 25LBS
- Newly Weds E54564-BREADER X5-NET WT 25LBS
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