Skip to main content
High RiskFDA
Ca Botana International, Inc.
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Av...
Drugs·2,090 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego,...
Topical Drugs·470 affected·Oct 10, 2025
High RiskFDA
Samsung Bioepis Co., Ltd.
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a ...
Injectable Drugs·5,518 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BO...
Drugs·555 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A...
Drugs·805 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC...
Drugs·1,167 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC...
Drugs·4,890 affected·Oct 10, 2025
High RiskFDA
The Harvard Drug Group Llc
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indi...
Oral Drugs·0 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, ...
Topical Drugs·810 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San D...
Drugs·874 affected·Oct 10, 2025
High RiskFDA
Quva Pharma, Inc.
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syrin...
Injectable Drugs·75,885 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, P...
Drugs·3,295 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Dieg...
Drugs·1,401 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, ND...
Drugs·1,617 affected·Oct 10, 2025
High RiskFDA
Ca Botana International, Inc.
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35...
Topical Drugs·4,890 affected·Oct 10, 2025
High RiskFDA
Rong Shing Trading Ny Inc
Aojia Dried Red Bayberry; packaged in 5.6oz (160g) clear plastic bottle; UPC 6942514920327
Produce·10 affected·Oct 9, 2025
High RiskFDA
Singh Trading Inc. Dba Roshni Foods
Roshni Cinnamon Powder, 3.5 oz (100g). This product is packaged in clear plastic pouches.
Food·48 affected·Oct 9, 2025
High RiskFDA
Ibspot
Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang x...
Topical Drugs·3 affected·Oct 9, 2025
High RiskFDA
Usv Private Limited
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rou...
Ophthalmic Drugs·8,952 affected·Oct 9, 2025
High RiskFDA
Amerisource Health Services Llc
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687...
Oral Drugs·27,868 affected·Oct 9, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Onl...
Oral Drugs·172,263 affected·Oct 9, 2025
High RiskFDA
Myofunctional Research Company Usa
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 differ...
Medical Devices·436 affected·Oct 9, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106...
Medical Implants·35,376 affected·Oct 9, 2025
High RiskFDA
B-k Medical A/s
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
Medical Devices·1,697 affected·Oct 9, 2025
High RiskFDA
B-k Medical A/s
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Medical Devices·895 affected·Oct 9, 2025
High RiskFDA
B-k Medical A/s
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Medical Devices·567 affected·Oct 9, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller...
Medical Implants·2,424 affected·Oct 9, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Co...
Medical Implants·248 affected·Oct 9, 2025
High RiskFDA
Pivotal Health Solutions, Inc.
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Medical Devices·34 affected·Oct 9, 2025
High RiskFDA
B-k Medical A/s
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus...
Medical Devices·4,426 affected·Oct 9, 2025
High RiskFDA
B-k Medical A/s
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Medical Devices·496 affected·Oct 9, 2025
High RiskFDA
Astrazeneca Pharmaceuticals
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distrib...
Injectable Drugs·916 affected·Oct 8, 2025
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: ...
Medical Devices·1,528 affected·Oct 8, 2025
High RiskFDA
Cellavision Ab
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 bar...
Medical Devices·688 affected·Oct 8, 2025
High RiskFDA
Sterilmed, Inc.
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC U...
Surgical Devices·6 affected·Oct 8, 2025
High RiskFDA
Nutrition For Longevity
Loaded Veggie Grain Bowl; NET WT. 10/90 OZ (309g) NO UPC Identifying N4L code: V3FR
Food·635 affected·Oct 7, 2025
High RiskFDA
Eagle Spice And Extract Co., Inc.
Eagle Spice Ground Ginger 16 oz.
Food·2,476 affected·Oct 7, 2025
High RiskFDA
Freshrealm
Loaded Veggie Grain Bowl; Net Wt. 10.90 Oz (309g) GTIN code: 00818905028162
Food·635 affected·Oct 7, 2025
High RiskFDA
Del Mar Food Products Corp.
ORGANIC IQF CHOPPED SPINACH 35 lbs. Net Weight Product is not ready to eat. For food safety, cook to an internal temperature of 165 degr...
Produce·966 affected·Oct 7, 2025
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsul...
Oral Drugs·291,512 affected·Oct 7, 2025
High RiskFDA
Rising Pharma Holding, Inc.
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. E...
Oral Drugs·2,064 affected·Oct 7, 2025
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsul...
Oral Drugs·181,659 affected·Oct 7, 2025
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsul...
Oral Drugs·107,673 affected·Oct 7, 2025
High RiskFDA
Philips Respironics, Inc.
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: ...
Respiratory Devices·56 affected·Oct 7, 2025
High RiskFDA
Meridian Bioscience Inc
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Diagnostic Devices·109 affected·Oct 7, 2025
High RiskFDA
Trividia Health, Inc.
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Diabetes Devices·601 affected·Oct 7, 2025
High RiskFDA
Meridian Bioscience Inc
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Diagnostic Devices·109 affected·Oct 7, 2025
High RiskFDA
Sno Pac Foods Inc
Frozen Organic Spinach Net Wt. 10 oz (283.5g) poly bags packaged under the following brands: 1. Sno Pac Frozen Vegetables, UPC 0 24284...
Produce·4,006 affected·Oct 6, 2025