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High RiskFDA
B Braun Medical Inc
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWEN...
Medical Devices·2,450 affected·Sep 18, 2025
CriticalFDA
D & M Smoked Fish, Inc.
Haifa COLD SMOKED SALMON 8 OZ.
Seafood·2,022 affected·Sep 17, 2025
High RiskFDA
Pepsico Inc
Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk. Outer case label reads as , "*** Lipton Green Tea Citrus (25g sugar)***" In...
Beverages·2,854 affected·Sep 17, 2025
CriticalFDA
D & M Smoked Fish, Inc.
Haifa COLD SMOKED SEABASS 8 OZ
Food·348 affected·Sep 17, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403...
Topical Drugs·13,824 affected·Sep 17, 2025
High RiskFDA
Park Avenue Compounding
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, ND...
Drugs·858 affected·Sep 17, 2025
High RiskFDA
Baxter Healthcare Corporation
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermomete...
Medical Devices·5,209 affected·Sep 17, 2025
High RiskFDA
Cpm Medical Consultants, Llc.
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, ...
Medical Devices·3,317 affected·Sep 17, 2025
CriticalFDA
Percussionaire Corporation
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Val...
Respiratory Devices·59,160 affected·Sep 17, 2025
High RiskFDA
Enterix, Inc.
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure O...
Medical Devices·201,426 affected·Sep 17, 2025
High RiskFDA
Sprout Organics Inc.
6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGAN...
Beverages·9,873 affected·Sep 16, 2025
High RiskFDA
Lawrence Wholesale Llc
Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UPC: 011110622952 Shrimp Cocktail Bowl; 17oz clear plastic retail packaging. ...
Seafood·8,400 affected·Sep 16, 2025
RecallFDA
Gansu Zhaofeng Agricultural Development Co., Ltd.
G&L Food Dried Bean Curd Net WT 17.6 OZ (500G) INGREDIENTS: Soybean, Water, Magnesium Chloride as Preservative CONTAINS: Soybean 121C wa...
Beverages·42,552 affected·Sep 16, 2025
High RiskFDA
Lawrence Wholesale Llc
16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised...
Seafood·4,871 affected·Sep 16, 2025
CriticalFDA
Integradose Compounding Services Llc
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, M...
Injectable Drugs·853 affected·Sep 16, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, ...
Oral Drugs·54,432 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Devices·45 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Devices·3 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological sy...
Surgical Devices·19 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Devices·3 affected·Sep 16, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product ...
Medical Devices·9,177 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices·17 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices·50 affected·Sep 16, 2025
High RiskFDA
Severn Peanut Company Llc
MIXED NUTS Roasted & Salted NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMOND...
Food·516 affected·Sep 15, 2025
High RiskFDA
Graviti Pharmaceuticals Private Limited
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Li...
Oral Drugs·46,512 affected·Sep 15, 2025
High RiskFDA
Amerisource Health Services Llc
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Col...
Oral Drugs·360 affected·Sep 15, 2025
High RiskFDA
Alcon Research Llc
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTA...
Medical Devices·28,323 affected·Sep 15, 2025
High RiskFDA
Mars Foods Us
Ben's Original Ready Rice Long Grain & Wild, 8.8oz., UPC 0 54800 42331 6. 12 retail units per wholesale case
Food·1,075 affected·Sep 12, 2025
High RiskFDA
Mars Foods Us
Ben's Original Ready Rice Whole Grain Brown, 8.8oz., UPC 0 54800 42334 7. 12 retail units per wholesale case.
Food·315 affected·Sep 12, 2025
High RiskFDA
M.o.m Enterprises, Llc.
Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitam...
Produce·46,752 affected·Sep 12, 2025
High RiskFDA
Mars Foods Us
Ben's Original Ready Rice Original Long Grain White, 8.8oz., UPC 0 54800 42333 0. 12 retail units per wholesale case
Food·273 affected·Sep 12, 2025
High RiskFDA
Private Label Skin Care Inc.
edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
Drugs·0 affected·Sep 12, 2025
High RiskFDA
Private Label Skin Care Inc.
ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
Drugs·125 affected·Sep 12, 2025
RecallFDA
Jb Chemicals And Pharmaceuticals Ltd
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals ...
Injectable Drugs·9,936 affected·Sep 12, 2025
RecallFDA
Letco Medical Llc
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Drugs·173 affected·Sep 12, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major ...
Oral Drugs·1,394 affected·Sep 12, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major ...
Oral Drugs·506 affected·Sep 12, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major P...
Oral Drugs·1,256 affected·Sep 12, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pha...
Oral Drugs·2,064 affected·Sep 12, 2025
High RiskFDA
Private Label Skin Care Inc.
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210
Drugs·0 affected·Sep 12, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major ...
Oral Drugs·866 affected·Sep 12, 2025
High RiskFDA
Private Label Skin Care Inc.
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, ...
Topical Drugs·0 affected·Sep 12, 2025
High RiskFDA
Private Label Skin Care Inc.
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
Drugs·0 affected·Sep 12, 2025
RecallFDA
Jb Chemicals And Pharmaceuticals Ltd
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals ...
Injectable Drugs·13,440 affected·Sep 12, 2025
High RiskFDA
Private Label Skin Care Inc.
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Drugs·0 affected·Sep 12, 2025
High RiskFDA
Medtronic Perfusion Systems
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Respiratory Devices·26 affected·Sep 12, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Cardiac Devices·28 affected·Sep 12, 2025
High RiskFDA
Noah Medical Corporation
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its a...
Diagnostic Devices·47 affected·Sep 12, 2025