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
CriticalFDA
Medline Industries, Lp
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Medical Devices·828 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
High RiskFDA
Northwind Pharmaceuticals Llc
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-cou...
Oral Drugs·96 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L211 PROPONENT DR SL MRI Pacemaker
Cardiac Devices·106,536 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number S702, ALTRUA 2 DR SL Pacemaker
Cardiac Devices·4,055 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U128, VALITUDE CRT-P EL MRI
Medical Devices·28,911 affected·Aug 20, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Package...
Cardiac Devices·71 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L231, PROPONENT DR EL MRI Pacemaker
Cardiac Devices·63,851 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L101, ESSENTIO DR SL Pacemaker
Cardiac Devices·22,714 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Cardiac Devices·3,146 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U226, VISIONIST CRT-P EL
Medical Devices·1,050 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
PROPONENT SR SL (Model L200)
Medical Devices·1,380 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Medical Devices·41,191 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L221 PROPONENT DR EL Pacemaker
Cardiac Devices·3,592 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Cardiac Devices·190,088 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Medical Devices·34,180 affected·Aug 20, 2025
High RiskFDA
Microsurgical Technology Inc
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Medical Devices·8 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L121 ESSENTIO DR EL Pacemaker
Cardiac Devices·10,833 affected·Aug 20, 2025
High RiskFDA
Southwind Foods Llc Dba Great American Seafood Imports Co.
Best Yet; Arctic Shores; and Great American branded Frozen cooked shrimp; 1 Pound/ 12 OZ/ 6 OZ/ 2 Pound plastic bag; (Various Brands) UPC...
Seafood·11,081 affected·Aug 19, 2025
High RiskFDA
Hershey Creamery Co.
Hershey s Ice Cream, Green Mint Chip (GMC) Bulk, 3 gallons, 1 unit , bulk can- a cardboard tub with metal rings and cardboard lid
Dairy·81 affected·Aug 19, 2025
High RiskFDA
Southwind Foods Llc Dba Great American Seafood Imports Co.
Sand Bar; Great American; and First Street branded Frozen raw shrimp; 2 pound plastic bag; UPC#: 011110641182; 829944010612; 04151217947...
Seafood·11,081 affected·Aug 19, 2025
RecallFDA
Medline Industries, Lp
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medlin...
Topical Drugs·2,680 affected·Aug 19, 2025
High RiskFDA
Lannett Company Inc.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bot...
Oral Drugs·4,848 affected·Aug 19, 2025
High RiskFDA
Greiner Bio-one North America, Inc.
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner ...
Medical Devices·1,980,000 affected·Aug 19, 2025
CriticalFDA
B Braun Medical Inc
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Injectable Drugs·47,148 affected·Aug 18, 2025
High RiskFDA
Amneal Pharmaceuticals, Llc
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Sol...
Oral Drugs·3,363 affected·Aug 18, 2025
High RiskFDA
Amneal Pharmaceuticals, Llc
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral So...
Oral Drugs·14,923 affected·Aug 18, 2025
High RiskFDA
Amneal Pharmaceuticals, Llc
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Sol...
Oral Drugs·7,228 affected·Aug 18, 2025
High RiskFDA
Amneal Pharmaceuticals, Llc
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; ...
Oral Drugs·60,072 affected·Aug 18, 2025
High RiskFDA
Amneal Pharmaceuticals, Llc
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Soli...
Oral Drugs·13,130 affected·Aug 18, 2025
CriticalFDA
B Braun Medical Inc
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Injectable Drugs·46,032 affected·Aug 18, 2025
High RiskFDA
Boston Scientific Corporation
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Medical Devices·18 affected·Aug 18, 2025
High RiskFDA
Aesculap Ag
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Medical Devices·1 affected·Aug 18, 2025
High RiskFDA
Corneat Vision, Ltd.
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Surgical Devices·630 affected·Aug 18, 2025
High RiskFDA
Boston Scientific Corporation
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Medical Devices·1 affected·Aug 18, 2025
High RiskFDA
Corneat Vision, Ltd.
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
Medical Devices·180 affected·Aug 18, 2025
High RiskFDA
Tampa Maid Foods, Llc
Clean-tail Coconut Farm Raise Breaded Butterfly Shrimp Clean Tail (21/25 CT per pound) in bulk packaging, corrugated master cartons. Mast...
Dairy·31 affected·Aug 16, 2025
High RiskFDA
Tampa Maid Foods, Llc
ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC (SYSCO) Cleantail Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corru...
Dairy·1,200 affected·Aug 16, 2025
High RiskFDA
Tampa Maid Foods, Llc
Panko Style Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 l...
Dairy·776 affected·Aug 16, 2025
High RiskFDA
Beaver Street Fisheries, Inc.
Great Value branded and Sea Best branded raw frozen shrimp in bulk packaging, master cartons. Master carton case is 20 lbs (10 x 2lbs re...
Seafood·33,164 affected·Aug 15, 2025