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High RiskFDA
Dermarite Industries, Llc
PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tu...
Topical Drugs·381,619 affected·Aug 27, 2025
High RiskFDA
Amerisource Health Services Llc
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus,...
Oral Drugs·1,062 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, ...
Drugs·37,272 affected·Aug 27, 2025
High RiskFDA
Amerisource Health Services Llc
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging...
Oral Drugs·1,757 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 6192...
Supplements·7,736 affected·Aug 27, 2025
High RiskFDA
Atlantic Management Resources Ltd.
Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 662337...
Drugs·72 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC...
Drugs·15,465 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Ave...
Drugs·37,379 affected·Aug 27, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesc...
Injectable Drugs·270,125 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61...
Drugs·115,994 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaR...
Drugs·576 affected·Aug 27, 2025
High RiskFDA
Amerisource Health Services Llc
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-4...
Oral Drugs·2,708 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC...
Topical Drugs·57,041 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz ...
Drugs·8,378 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson M...
Drugs·5,876 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue,...
Topical Drugs·3,178 affected·Aug 27, 2025
High RiskFDA
Dermarite Industries, Llc
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g...
Topical Drugs·0 affected·Aug 27, 2025
High RiskFDA
Vision Rt Ltd
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Medical Devices·56 affected·Aug 27, 2025
High RiskFDA
Extract Labs, Inc.
Blue Razz 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD ...
Supplements·19,810 affected·Aug 26, 2025
High RiskFDA
Extract Labs, Inc.
Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength: 10mg CBD and 10mg D9 THC per gummy ...
Produce·2,180 affected·Aug 26, 2025
High RiskFDA
Extract Labs, Inc.
Elderberry 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD...
Produce·19,720 affected·Aug 26, 2025
High RiskFDA
Extract Labs, Inc.
Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD an...
Supplements·19,750 affected·Aug 26, 2025
High RiskFDA
B Braun Medical Inc
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA,...
Drugs·16,228 affected·Aug 26, 2025
High RiskFDA
B Braun Medical Inc
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Injectable Drugs·26,316 affected·Aug 26, 2025
High RiskFDA
Osstem Implant Co., Ltd.
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Medical Devices·0 affected·Aug 26, 2025
High RiskFDA
Osstem Implant Co., Ltd.
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Medical Devices·0 affected·Aug 26, 2025
High RiskFDA
Abdallah Incorporated
Sea Salt Caramel Dark Miniature, Item ID: 2237 ML. Packed On (YYMMDD): 25-07-22. 5.20 lb. Box. Abdallah Candies
Food·1 affected·Aug 25, 2025
High RiskFDA
Abdallah Incorporated
Cream Caramels, Milk, Item ID: 2210L. Packed On (YYMMDD): 25-06-16. 6.26 lb. Box. Abdallah Candies
Dairy·1 affected·Aug 25, 2025
High RiskFDA
Avkare
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38...
Oral Drugs·1,512 affected·Aug 25, 2025
High RiskFDA
Avkare
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 3...
Oral Drugs·2,003 affected·Aug 25, 2025
High RiskFDA
Grace & Fire Pty Ltd
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per t...
Drugs·44,497 affected·Aug 22, 2025
High RiskFDA
Grace & Fire Pty Ltd
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, U...
Drugs·49,275 affected·Aug 22, 2025
High RiskFDA
Coopervision, Inc.
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, ...
Medical Devices·4,140 affected·Aug 22, 2025
High RiskFDA
Ge Medical Systems, Llc
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001,...
Medical Devices·29,225 affected·Aug 22, 2025
High RiskFDA
Coopervision, Inc.
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moul...
Medical Devices·90 affected·Aug 22, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT EG6+ cartridge. List Number: 03P77-25.
Medical Devices·547,250 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices·3,790 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Medical Devices·2,700 affected·Aug 21, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Medical Devices·9,067,050 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices·490 affected·Aug 21, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Medical Devices·8,962,450 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Medical Devices·160 affected·Aug 21, 2025
High RiskFDA
The J.m. Smucker Company
Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 oz twin pack UPC 8 88109 01002 7; 10-1.28 oz carton (12.7 oz) UPC 8 88109 1106...
Bakery & Grains·60,630 affected·Aug 20, 2025
High RiskFDA
Jessie Lord Bakery, Llc
Lemon Meringue Pie, 8" round. Net Wt. 27 OZ; Refrigerate after opening Item Code 31811; UPC: 8 85523 31811 1;Jessie's Lemon Meringue Pie...
Food·136,252 affected·Aug 20, 2025
High RiskFDA
Itacate Foods Llc
CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilantro base that takes no time to rehydrate. NET WT 4.0 OZ (115G) INGREDIENTS: *...
Beverages·154 affected·Aug 20, 2025
High RiskFDA
Itacate Foods Llc
CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped w...
Dairy·566 affected·Aug 20, 2025
High RiskFDA
Baxter Healthcare Corporation
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield...
Injectable Drugs·13,000 affected·Aug 20, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis,...
Oral Drugs·26,628 affected·Aug 20, 2025