Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Anderson Candy Company, Llc
Peanut rounds 2.25 oz and 3 oz
Food·960,000 affected·Aug 15, 2025
RecallFDA
Stanley Pearlman Enterprises, Inc.
NAFCO, WHITING FILLET SKIN-ON BONELESS IQF, 2 lb., Cases are corrugate. The product is individually frozen and packed in food contact ret...
Frozen Food·141 affected·Aug 15, 2025
CriticalFDA
New Acai Amazonas Llc
Organic Mango Freeze Dried Powder, Bulk, 15-kilogram boxes (2 packs of 7.5 kilograms in a carton box), 7.5kg packaged in multi-wall kraft...
Food·255 affected·Aug 15, 2025
High RiskFDA
Maquet Cardiovascular, Llc
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Cardiac Devices·126 affected·Aug 15, 2025
High RiskFDA
Exactech, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINE...
Medical Devices·11,542 affected·Aug 15, 2025
High RiskFDA
Maquet Cardiovascular, Llc
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Cardiac Devices·28,331 affected·Aug 15, 2025
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA0001...
Medical Devices·2,278 affected·Aug 15, 2025
High RiskFDA
Admiralty Island Fisheries Inc Dba Aquastar (usa) Corp.
Frozen AquaStar Breaded Shrimp, Butterfly, Clean-Tail, 16/20 count/lb. 3 lbs. package. Net wt. per case 36lbs. (12x3lbs. packages per cas...
Dairy·126 affected·Aug 14, 2025
High RiskFDA
Admiralty Island Fisheries Inc Dba Aquastar (usa) Corp.
Frozen Mercado Kroger Cooked Shrimp - Medium - Peeled - Tail-Off - Shrimp Pieces. 2 lbs. package. Net wt. per case 10lbs. (5x2lb package...
Seafood·18,000 affected·Aug 14, 2025
High RiskFDA
Admiralty Island Fisheries Inc Dba Aquastar (usa) Corp.
AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce. Each case consists of 6x6 oz packages, UPC 19434612191. Distributed by Aqua St...
Seafood·22,500 affected·Aug 14, 2025
CriticalFDA
Fresh & Ready Foods Llc
Tuscan Artichoke and Mozzarella Salad; Keep Refrigerated, NET WT: 8.5 OZ, UPC# 6 82906 90935 1 Manufactured by Fresh and Ready Foods LLC...
Produce·233 affected·Aug 13, 2025
CriticalFDA
Fresh & Ready Foods Llc
Spanish Club Ciabatta; Keep Refrigerated, NET WT: 10.5 OZ, UPC# 6 82906 90933 7 Manufactured by Fresh and Ready Foods LLC, San Fernando,...
Food·233 affected·Aug 13, 2025
High RiskFDA
Dollins Pecan Co, Inc
Product Name: Blueberry Pretzels " Brand Name: HEB " Description: 8oz HEB Blueberry Flavored Yogurt Pretzels " UPC Codes: 9787011400 " Lo...
Dairy·468 affected·Aug 13, 2025
High RiskFDA
Sandoz Inc
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belg...
Drugs·1,680 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Medical Devices·45 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Medical Devices·0 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Medical Devices·10 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 36...
Medical Devices·206 affected·Aug 13, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Radiology Solutions software version 14.2.2
Medical Devices·12 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Medical Devices·210 affected·Aug 13, 2025
High RiskFDA
Beta Bionics, Inc.
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Medical Devices·15 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Medical Devices·81 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Numbe...
Medical Devices·33 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Medical Devices·3 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Medical Devices·0 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Medical Devices·6 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number...
Medical Devices·73 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Medical Devices·190 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model...
Medical Devices·181 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Medical Devices·0 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010...
Medical Devices·643 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-...
Medical Devices·158 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 860010-1L
Medical Devices·26 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Medical Devices·15 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Medical Devices·0 affected·Aug 13, 2025
High RiskFDA
H & N Group Inc.
Frozen shrimp in bulk packaging. 20 lbs (10 x 2 lbs blocks); 20 lbs (20 x 1 lbs blocks); 9 lbs case UPC# SH0176; SH0430; SH0320; SH0369;...
Seafood·17,214 affected·Aug 12, 2025
High RiskFDA
Bakers Authority Llc
Baker's Authority Three Seed Mix; 5lb bag; stored dry at room temperature; packaged in silver bag
Food·78 affected·Aug 12, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Grilling Camembert with Tapenade & Roasted Tomatoes - 10 OZ - Overwrapped black and gold metal tray UPC: 2-77297-XXXXX-0 (X - ...
Produce·4,884 affected·Aug 12, 2025
CriticalFDA
Quesito El Establo
Quesito El Establo brand Spanish Cheese QUESITO COLOMBIANO; INGREDIENTS: Milk, Cheese Cultures, Salt, Vitamins C and D; INGREDIENTES: Lec...
Dairy·800 affected·Aug 12, 2025
High RiskFDA
Bakers Authority Llc
Baker's Authority Everything Bagel Mix; 5lb bag and 1lb bag; stored dry at room temperature; packaged in silver bag
Food·197 affected·Aug 12, 2025
High RiskFDA
Domino Foods Inc
PURE CANE GRANULATED SUGAR, NET WT 50 LB (22.67kg), Distributed by Domino Foods, Inc., Yonkers, NY 10705, STORE IN A COOL, DRY PLACE
Food·4,500 affected·Aug 12, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Medium Camembert Soft Ripened Cheese - 8.8oz - Round wooded container; UPC: 2-77467-00000-7 , 0-77890-53515-8
Dairy·4,884 affected·Aug 12, 2025
High RiskFDA
Bakers Authority Llc
Baker's Authority Graham Cracker Meal; 5lb bag; stored dry at room temperature; packaged in silver bag
Bakery & Grains·70 affected·Aug 12, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Assorted Cheese Flight - Varies (sold by the lb) - Black Plastic container with clear lid UPC: 2-77100-XXXXX-5 (X - varies by ...
Dairy·4,884 affected·Aug 12, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Caramel Apple Pecan Topped Brie Cheese -Small - 13 OZ - Clear plastic container with lid UPC: 2-77645-XXXXX-3 (X - varies by w...
Dairy·4,884 affected·Aug 12, 2025
High RiskFDA
Viona Pharmaceuticals Inc
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changoda...
Topical Drugs·3,960 affected·Aug 12, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Ass...
Medical Devices·8,413 affected·Aug 12, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assis...
Medical Devices·25,389 affected·Aug 12, 2025