Class III Recalls
1,798 totalClass III recalls involve products that are unlikely to cause any health problems, but still violate FDA rules or standards. This could be a labeling issue, a minor quality problem, or something similar. These are the least urgent type of recall.
Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufac...
Terminated
Teligent Pharma, Inc.
· Jul 28, 2021
· Drug
Heidi's Brownies is packaged in saran wrap in a plastic bag with a twist tie, 3 oz (85g). Label is read in pa...
Terminated
Heidi Remington
· Jul 28, 2021
· Food
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Di...
Terminated
Lnk International, Inc.
· Jul 28, 2021
· Drug
Kroger brand, Vitamin D3 125 mcg softgels, 100 count, Green HDPE packaging
Terminated
Bountiful Trading Inc
· Jul 28, 2021
· Food
B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935...
Terminated
Grato Holdings, Inc.
· Jul 21, 2021
· Drug
LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Par...
Terminated
Partner Therapeutics Inc
· Jul 21, 2021
· Drug
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division...
Terminated
Bausch Health Companies, Inc.
· Jun 30, 2021
· Drug
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. N...
Terminated
Avkare Inc.
· Jun 23, 2021
· Drug
BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples)
Terminated
Lopez Gonzalez Santana Corporation
· Jun 23, 2021
· Food
Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Faci...
Terminated
Prisma Health Outsourcing Facility
· Jun 23, 2021
· Drug
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laborato...
Terminated
Dr. Reddy'S Laboratories, Inc.
· Jun 23, 2021
· Drug
Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation...
Terminated
Mckesson Corporation Dba Mckesson Drug Company
· Jun 16, 2021
· Drug
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Si...
Terminated
Medline Industries Inc
· Jun 16, 2021
· Drug
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care...
Terminated
Fresenius Medical Care Holdings, Inc.
· Jun 16, 2021
· Drug
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per cart...
Terminated
Mylan Institutional Llc
· Jun 9, 2021
· Drug
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai,...
Terminated
Ascend Laboratories, Llc
· Jun 2, 2021
· Drug
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited,...
Terminated
Dr. Reddy'S Laboratories, Inc.
· Jun 2, 2021
· Drug
Dole Yellow cling Peach Slices in 100% Fruit Juice. Snack & Store Fridge Pack. Net Wt 15 oz. (425g). UPC...
Terminated
Dole Packaged Foods, Llc
· Jun 2, 2021
· Food
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Po...
Terminated
Nomax Inc
· May 26, 2021
· Drug
BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
Terminated
Lopez Gonzalez Santana Corporation
· May 26, 2021
· Food
NOW 4x6 Acidophilus, 60 capsules per retail bottle. Item number 2920. UPC 7 33739 02920 1
Terminated
Now Health Group Inc.
· May 26, 2021
· Food
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020...
Terminated
Sigmapharm Laboratories Llc
· May 26, 2021
· Drug
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd...
Terminated
Kvk Tech, Inc.
· May 26, 2021
· Drug
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL...
Terminated
Sun Pharmaceutical Industries Inc
· May 26, 2021
· Drug
Driscoll's Fresh Blackberries; 6 oz. or 18 oz. containers.
Terminated
Driscoll'S Inc.
· May 19, 2021
· Food
Botanic Choice Green Tea Leaf Extract (3:1 Extract), Alcohol Free Liquid Extract, 1 FLOZ., in glass jar with d...
Terminated
Indiana Botanic Gardens, Inc
· May 19, 2021
· Food
BTREX PLUS, Dietary Supplement 100 Caplets
Terminated
Lopez Gonzalez Santana Corporation
· May 19, 2021
· Food
8 pound cases containing 1 pound cryovac wrapped packages of Caldarello Italian Sausage with a case code of 33...
Completed
4G Meat Processing Llc
· May 14, 2021
· USDA
0.80 to 1.5-lb. vacuum-sealed or butcher paper wrapped packages containing “Atlas Meat Pork Breakfast Ssg.”, 0...
Completed
Atlas Meat Company
· May 14, 2021
· USDA
6-oz packages of Whole Foods Market “Chicken Salad” with a “Sell By” date of 1/24/2017.
Completed
Willow Tree Poultry Farm, Inc.
· May 14, 2021
· USDA
045-2016
Completed
Burger'S Ozark Country Cured Hams, Inc.
· May 14, 2021
· USDA
008-2016
Completed
· May 14, 2021
· USDA
Vacuum-sealed packages containing “Harry & David Ready to Heat Fully Cooked Turkey without Giblets” with a...
Completed
Burger'S Ozark Country Cured Hams, Inc.
· May 14, 2021
· USDA
118-2015
Completed
Branding Iron Holdings - Holten Meat
· May 14, 2021
· USDA
115-2015
Completed
Swanson Meat Co.
· May 14, 2021
· USDA
041-2016
Completed
· May 14, 2021
· USDA
117-2016
Completed
King Meat Service Inc.
· May 14, 2021
· USDA
10-lb. poly bag packages containing thin-sliced (shaved) pieces of “Frank Bertolino Beef Co. Inc. Certified An...
Completed
Bertolino Foods, Inc.
· May 13, 2021
· USDA
2-lb. black Styrofoam plastic wrapped trays containing ground beef labeled “CERTIFIED ANGUS BEEF GROUND CHUCK...
Completed
Jbs Prepared Foods-Tupelo Facility
· May 13, 2021
· USDA
12-oz packages of “Morrison Aussie Travelers’ Pies, Hand-Held 2 Aussie Pies Steak & Mushroom,” with sell-b...
Completed
Corn Maiden Foods, Inc.
· May 13, 2021
· USDA
2.78-oz. pouches of “Great Value Minis – Bites of Chicken Sausage and Bouillon” with Packaging Dates of “01/01...
Completed
Century Packing Corp.
· May 13, 2021
· USDA
104-2018
Completed
· May 13, 2021
· USDA
054-2018
Completed
Land O'Frost, Inc.
· May 13, 2021
· USDA
040-2018
Completed
Great Kitchens Food Company
· May 13, 2021
· USDA
059-2018
Completed
Tillamook Country Smoker, Llc
· May 13, 2021
· USDA
067-2018
Completed
Stoneridge Wholesale Division Llc
· May 13, 2021
· USDA
10-lb. bulk boxes containing 40 patties per box of Rochester Meat Company “Pork Sausage Patties,” bearing the...
Completed
Branding Iron Holdings
· May 13, 2021
· USDA
003-2018
Completed
Discoverfresh Foods
· May 13, 2021
· USDA
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswic...
Terminated
Heritage Pharmaceuticals Inc
· May 12, 2021
· Drug
Thai Home brand Sweet Chili Paste (Num Prik Pao) packaged in glass jars. Net weight 6.5 oz (180g). Refrigerat...
Terminated
Jansala & Foods Llc
· May 12, 2021
· Food