FDA recalls: September 2021
Every food and drug recall report the FDA published in September 2021: 192 reports, 37 of them Class I.
- Recall reports
- 192
- Class I (serious)
- 37
- Food
- 115
- Drugs
- 77
- Sep 29, 2021Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed…Drug · The Harvard Drug GroupFailed Dissolution SpecificationsClass II
- Sep 29, 2021Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufac…Drug · The Harvard Drug GroupFailed Dissolution SpecificationsClass II
- Sep 29, 2021Chantix (varenicline) tablets 0Drug · Pfizer Inc.CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limitClass II
- Sep 29, 2021Chantix (varenicline) tablets 0Drug · Pfizer Inc.CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limitClass II
- Sep 29, 2021Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, D…Drug · Pfizer Inc.CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limitClass II
- Sep 29, 2021Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets eac…Drug · Pfizer Inc.CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limitClass II
- Sep 29, 2021Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Au…Drug · Aurobindo Pharma USA Inc.Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.Class II
- Sep 29, 2021Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged…Drug · American Health PackagingFailed Impurities/Degradation SpecificationsClass III
- Sep 29, 2021Promethazine Syrup Plain, 6Drug · Morton Grove Pharmaceuticals, Inc.CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Class II
- Sep 29, 2021Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6Drug · Morton Grove Pharmaceuticals, Inc.CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Class II
- Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufacture…
- Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103…
- Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28
- X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box
- Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 sing…
- Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured b…
- Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc
- Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by:…
- Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by:…
- Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Gl…
- Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc
- Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only…
- Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count…
- Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Da…
- Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80
- 1. Dickies Seafood Cooked & Spiced Shrimp (12 oz) UPC 5240700804 Sell by 9/8/2021 & 9/1…
- 1. "***JOY***Tamarind Chutney***NET WT 8 OZ (228g)***06.19 BEST BY 093022***INGREDIENTS…
- 2. "***JOY***Coriander Chutney***NET WT 8 OZ (228g)***07 28 BEST BY 073022***INGREDIENT…
- "***JOY***Mint Chutney***NET WT 8 OZ (228g)***INGREDIENTS: MINT, GREEN CHILLIES, SALT,…
- "***JOY***Green Chilli Chutney***NET WT 8 OZ (228g)***INGREDIENTS: GREEN CHILLIES, VINE…
- Carrot cake (no brand), 6 inch and 8 inch sizes, on plastic base, with clear plastic dome
- DAIYA CHEESE VEGAN CHEDDAR STYLE SLICE 8/7
- FLEISCHMANN'S YEAST COMPRESSED FRESH ESL 24/1lbs Paper/Foil overwrap
- GORDO'S AUTHENTIC MEXICAN RESTAURANT STYLE CHEESE DIP NET WT
- I SICILIANI PRIMOSALE PEPATO sheep's milk cheese with black pepper 2/5lbs Plastic over…
- IMPERIAL FRESH POTATO SWEET DICE 1/2, 4/5lbs Plastic overwrap tray
- IMPERIAL FRESH TOMATO ROMA DICED 3/8 TRAY 1/5lbs Plastic overwrap tray
- KEN'S STEAKHOUSE DRESSING ASIAN SESAME DRESSING 4/1gallon Plastic container Ken's Foods…
- Phillips Majestic Blue Colossal Clawfingers 20/40 6/12 oz CANS UPC 10070057145068 & Phi…
- MINOR'S SEAFOOD BASE NO MSG GF 6/16 OZ (1 lb) 453 G UNITS Plastic container (pint) glut…
- SUNNY CREEK SPROUT BEAN FRESH 1/5lbs Plastic bag
- Alfalfa Sprouts 12/4oz Plastic container, sold under the the brand names of: Sunny Cree…
- TULKOFF Ginger Puree 6/32oz Tubs UPC 1 00 70607 50015 6 Tulkoff Food Products, Inc
- Golden Natural Product Inc
- Daniele - PLAIN BULK (28 LB
- Kroger Kale Bag 16oz plastic bag 8 packages per case
- Banquet Cut European Style Cold Smoked Salmon, Item Number 2-92845, brand Gerard and Do…
- Oatmeal Cranberry Cookie, packed in closed bags, 12oz net wt
- Lemon Thyme Cookies, packed in closed bags, 12oz net wt
- Snickerdoodle Cookie, packed in closed bags, 12oz net wt
- Chocolate Chip Cookie, packed in closed bags, 12oz net wt
- Oatmeal Butterscotch Cookie, packed in closed bags, 12oz net wt
- Lemon Blueberry Scones, packed in closed box
- Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: R…
- Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8
- Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8
- Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sac…
- Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pha…
- Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist
- Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Telig…
- Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Me…
- Betamethasone Dipropionate Lotion USP (Augmented), 0
- MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/…
- Spironolactone Ophthalmic Solution 0
- AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers,…
- $7 Crab Cake Meal packaged in a 3 compartment plastic container
- Marketside Chocolate Candy Cookie Cake, 24 oz
- Salted Caramel, brand Full Tilt Ice Cream, packaged in 16oz pre-packed pints and 3 gall…
- Mexican Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3…
- Backyard mint chip, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and a…
- Dark Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 ga…
- Vanilla Bean, Full Tilt Ice Cream, packaged in 16oz pre packed pints and 3 gallon tubs
- Peanut Butter Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs
- Huckleberry Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs
- Thai Tea, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs
- Strawberry, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs
- Ube, Full Tilt Ice Cream brand, packaged in 3 gallon tubs
- All The Chocolate, Full Tilt Ice Cream brand, packaged in 3 gallon tubs
- Mint Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs
- Coffee Oreo, Full Tilt Ice Cream brand, packaged in 3 gallon tubs
- Purim Health Products: EpiGenius Kids Creamy Chocolate
- Vita Aid Keto-Elemental Nutrition (Chocolate), VA-958
- Vita Aid Keto-Elemental Nutrition (Thai), VA-958
- Vita Aid SynerClear (Unflavoured), VA-925
- Vita Aid SynerClear (Vanilla), VA-924
- Vita Aid SynerClear (Chocolate), VA-012
- Roasted Red Pepper 12" Supreme Flour Wraps, Tortilleria Sonora, Inc
- Jimbo's BLOODY MARY MIX
- Trader Joe's Nuts Raw California Walnut Baking Pieces NET WT
- Albanese World's Best Mini Gummi Butterflies 7
- Whole Foods Market - Vegan Croissant 4 Count CONTAINS WHEAT, SOY May contain other alle…
- Loki Fish Wild Keta Salmon Lox, packaged in a 4 oz
- HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer no…
- HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer no…
- QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16
- Fermentation Derived Pepsin Product packaging: 5 individual LDPE bags with a net weigh…
- Trader Joe's Super Spinach Salad with Quinoa, carrots, cranberries, chickpeas, edamame,…
- Banoful Top Orange Biscuit
- Cyclobenzaprine Hydrochloride Tablets, 7
- Cyclobenzaprine Hydrochloride Tablets, 7
- Cyclobenzaprine Hydrochloride Tablets, 7
- Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy
- MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/…
- MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8
- MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8…
- MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8
- MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8
- MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8…
- Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant G…
- Lidocaine Ointment USP, 5% Rx Only
- Artificial Tears Ointment, Lubricant Eye Ointment
- Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods…
- CHINA_GEL (Camphor 3
- CHINA-GEL WHITE (Camphor 3
- aulief (Organic Camphor 3
- BrightFarms Sunny Crunch
- BrightFarms Spring Mix
- BrightFarms Harvest Crunch
- BrightFarms 50/50 Spring & Spinach
- BrightFarms Lakeside Crunch
- BrightFarms Spring Crunch
- BrightFarms Butter Crisp
- BrightFarms Nutrigreens
- BrightFarms Mighty Romaine
- BrightFarms Spinach
- Cahill Cheddar with Porter PLU 93579 packaged in clear plastic
- Cahill Whiskey Cheddar Cheese packaged in clear plastic PLU 5478494884
- Strawberry Yogurt Granola Parfait packaged in clear plastic cups and labeled in the fol…
- Your Way Fresh, Sliced Banana + Strawberry Yogurt Parfait
- Your Way Fresh, Greek Yogurt + Peach Parfait
- Flourless Chocolate Torte, 14 oz
- Triple Berry Streusel Cheesecake, 20 oz
- 12 PC Shrimp Tempura Kabuki Roll [BR] UPC: 81244803670 Products were sold from Genji S…
- 12 PC Shrimp Tempura Kabuki Roll [WR UPC:81244803410 Products were sold from Genji Su…
- 12 PC Spicy Shrimp Tempura Roll [WR] UPC: 81244803385 Products were sold from Genji S…
- August Box of the Month NCA UPC: 84003140261 Products were sold from Genji Sushi coun…
- Double Shrimp BBQ Roll WR UPC: 81244803204 Products were sold from Genji Sushi counte…
- ONO SHRIMP POKE BOWL UPC:84003140699 Products were sold from Genji Sushi counters ins…
- Rainbow Sushi Set [WR] UPC:81244803418 Products were sold from Genji Sushi counters i…
- Sept Box of The Month (NCA) WR UPC: 84003140397 Products were sold from Genji Sushi c…
- Shrimp California Roll [BR] UPC: 81244803702 Products were sold from Genji Sushi coun…
- Shrimp California Roll [WR] UPC: 81244803442 Products were sold from Genji Sushi coun…
- Shrimp Summer Roll UPC:81282401393 Products were sold from Genji Sushi counters insid…
- Spicy Shrimp California Roll [WR] UPC: 81244803444 Products were sold from Genji Sush…
- Spicy Shrimp Inari 4 PC [WR] UPC: 81244803399 Products were sold from Genji Sushi cou…
- Spicy Shrimp Inari 4pc Kabuki [WR] UPC: 81244803408 Products were sold from Genji Sus…
- Spicy Shrimp Tempura Roll [WR] UPC: 81244803443 Products were sold from Genji Sushi c…
- WOK ST SHRIMP VEGGIE LO MEIN P UPC: 84003140247 Products were sold from Genji Sushi c…
- Wok st. Shrimp Lo Mein UPC: 84003140405 Products were sold from Genji Sushi counters…
- 12pc Shrimp Tempura Kabuki Roll WR UPC: 8 4003140626 2 Product was sold from Mai Sus…
- SPICY SHRIMP TEMPURA ROLL UPC: 81282401109 Product was sold from Mai Sushi counters…
- SPECIAL ROLL SUPER SET 16PC UPC: 81282401129 Product was sold from Mai Sushi counters…
- CHEF'S ASSORTED NIGIRI 6PC UPC: 81282401130 Product was sold from Mai Sushi counters…
- SCORPION ROLL UPC:81282401138 Product was sold from Mai Sushi counters inside New Lea…
- BR SPECIAL ROLL SUPER SET 16PCL UPC:81282401203 Product was sold from Mai Sushi count…
- COOKED VARIETY PACK UPC:81282401349 Product was sold from Mai Sushi counters inside N…
- SHRIMP MANGO FRESH ROLL UPC:81282401374 Product was sold from Mai Sushi counters insi…
- Raw Shelled Peanuts, Skins Removed, Split Nut Blanched Runner Peanuts, Net
- Hostess Soft White Hamburger Buns
- Hostess Soft White Hot Dog Buns
- Rocky Top Farms Cherry Butter sold in 1 gallon food service and 10oz retail sizes
- Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, N…
- Pi yen chin Ophthalmic Redness Reliever Drops Made in China
- Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intraveno…
- Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intraven…
- PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2
- PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc
- PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International…
- PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable Internationa…
- PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposab…
- PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposa…
- PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) S…
- FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only,…
- Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC B…
- Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12
- Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12
- Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc
- Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterp…
- Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manuf…
- Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd
- Trulicity (dulaglutide), 0
- Wegmans Sunflower Crunch Chopped Salad Kit: Includes Green Cabbage, Green Leaf Lettuce,…
- Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb
- Hiland 100% Pure Apple Juice From Concentrate No Sugar Added Pasteurized 4 FL OZ (118 m…
- Cahills Ireland Whiskey Cheese - 5lb
- 1. Cahills Ireland Original Irish Porter 5lbs.Waxed Deli Wheel 2. Cahills Ireland Orig…
- Cahills Ireland Red Wine - 5 lbs
- Lidl Preferred Selection-Irish Stout Cheddar - 7 oz
- Lidl Preferred Selection-Red Wine Cheddar - 7 oz
- Wavy Lay s Original Potato Chips UPC 0 28400 04380 9 packaged in flexible bag
- Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per…
- Crunchmaster Multi Grain Baked Gluten-Free Crackers 5-Seed Sesame, Amaranth, Flax, Chia…
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