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High RiskFDA
Asegua Therapeutics Llc
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an ...
Oral Drugs·18,541 affected·Mar 7, 2025
High RiskFDA
Direct Rx
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berli...
Drugs·16 affected·Mar 7, 2025
High RiskFDA
Consumer Product Partners, Llc
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL...
Topical Drugs·25,932 affected·Mar 7, 2025
High RiskFDA
Exela Pharma Sciences Llc
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx On...
Injectable Drugs·103,950 affected·Mar 7, 2025
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carto...
Oral Drugs·1,068 affected·Mar 7, 2025
High RiskFDA
Slate Run Pharmaceuticals
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piram...
Oral Drugs·2,444 affected·Mar 7, 2025
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton...
Oral Drugs·347 affected·Mar 7, 2025
High RiskFDA
Slate Run Pharmaceuticals
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piram...
Oral Drugs·56,790 affected·Mar 7, 2025
High RiskFDA
Direct Rx
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-c...
Drugs·875 affected·Mar 7, 2025
High RiskFDA
Ethicon Endo Surgery, Llc
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Medical Devices·792 affected·Mar 7, 2025
High RiskFDA
Ethicon Endo Surgery, Llc
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Medical Devices·37,080 affected·Mar 7, 2025
High RiskFDA
Great Lakes Coca-cola Distribution Llc
Coco-Cola Original Taste, 12 Fl Oz. (355mL). Can UPC 0 49000-00634 6. 12-can pack UPC 0 49000-02890 4. Canned Under Authority of the C...
Food·864 affected·Mar 6, 2025
High RiskFDA
Quva Pharma, Inc.
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injectio...
Injectable Drugs·2,310 affected·Mar 6, 2025
High RiskFDA
Quva Pharma, Inc.
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for...
Injectable Drugs·0 affected·Mar 6, 2025
High RiskFDA
Quva Pharma, Inc.
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for...
Injectable Drugs·1,765 affected·Mar 6, 2025
High RiskFDA
Fisher Diagnostics
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Diagnostic Devices·4,387 affected·Mar 6, 2025
CriticalFDA
Ge Medical Systems, Llc
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VG...
Diagnostic Devices·12,808 affected·Mar 6, 2025
High RiskFDA
Fisher Diagnostics
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Diagnostic Devices·1,699 affected·Mar 6, 2025
High RiskFDA
Blooming Import Inc.
Golden Crop Candy (10 oz. (283g) wrapped candies)
Snacks & Candy·74 affected·Mar 5, 2025
High RiskFDA
Blooming Import Inc.
Golden Crop Candy (8 oz. (227g) un-wrapped candies)
Snacks & Candy·74 affected·Mar 5, 2025
High RiskFDA
L'oreal Usa
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 36060005...
Drugs·0 affected·Mar 5, 2025
High RiskFDA
L'oreal Usa
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz...
Topical Drugs·14,460 affected·Mar 5, 2025
High RiskFDA
L'oreal Usa
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. ...
Drugs·2,226,801 affected·Mar 5, 2025
High RiskFDA
Strides Pharma, Inc.
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 643...
Topical Drugs·244,412 affected·Mar 5, 2025
High RiskFDA
Golden State Medical Supply Inc.
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Oral Drugs·2,601 affected·Mar 5, 2025
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663,...
Oral Drugs·1,223 affected·Mar 5, 2025
High RiskFDA
Strides Pharma, Inc.
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC ...
Topical Drugs·195,952 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catal...
Medical Devices·20 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Ca...
Medical Devices·22 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Medical Devices·474 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Medical Devices·0 affected·Mar 5, 2025
High RiskFDA
Advanced Bionics, Llc
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Medical Devices·6 affected·Mar 5, 2025
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Medical Devices·315 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Num...
Medical Devices·51 affected·Mar 5, 2025
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Medical Devices·20 affected·Mar 5, 2025
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
Medical Devices·738 affected·Mar 5, 2025
High RiskFDA
Dinstuhl's Fine Candy Company, Inc.
Dinstuhl's Cashew Crunch, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Cashews, Coconut, Corn Syrup...
Dairy·24 affected·Mar 4, 2025
High RiskFDA
Dinstuhl's Fine Candy Company, Inc.
Dinstuhl's Peanut Brittle, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Corn Syrup, Baking Soda, Pe...
Dairy·12 affected·Mar 4, 2025
CriticalFDA
Liaoning Cheng Da (usa) Inc
Wangzhine branded Hot Pot Sauce; Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001375
Food·3,650 affected·Mar 4, 2025
High RiskFDA
Dinstuhl's Fine Candy Company, Inc.
Dinstuhl's Pecan Brittle, NET WT 4 oz. (113g), individually packaged in cellophane bags; Ingredients: Sugar, Pecans, Corn Syrup, Butter, ...
Dairy·12 affected·Mar 4, 2025
CriticalFDA
Liaoning Cheng Da (usa) Inc
Wangzhine branded Hot Pot Sauce (SPICY); Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001382
Food·3,420 affected·Mar 4, 2025
High RiskFDA
Seattle Homemade Thai Llc
Panang Curry Tofu Vegan GF is a refrigerated and ready to eat product, packaged in plastic box, net wt. 13.5oz. UPC 88581 149928. Label ...
Dairy·12 affected·Mar 4, 2025
RecallFDA
Tristar Food Wholesale Co Inc
BaiWei ShanZhuang, Dried Seedless Plum Candy, 9.16 oz. (260g), plastic bags, 30 bags per case.
Snacks & Candy·50 affected·Mar 4, 2025
High RiskFDA
Chattem Inc
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured ...
Oral Drugs·180,696 affected·Mar 4, 2025
RecallFDA
Sun Pharmaceutical Industries Inc
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Di...
Oral Drugs·852 affected·Mar 4, 2025
RecallFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major ...
Oral Drugs·224 affected·Mar 4, 2025
RecallFDA
Sun Pharmaceutical Industries Inc
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, D...
Oral Drugs·12,876 affected·Mar 4, 2025
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Produ...
Diagnostic Devices·2,776,416 affected·Mar 4, 2025