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
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·58,416 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·175,920 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of Indi...
Oral Drugs·39,168 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·53,952 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·190,320 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·120,000 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·233,040 affected·Jan 29, 2025
High RiskFDA
Stryker Corporation
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Medical Devices·9,521 affected·Jan 29, 2025
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic ...
Medical Devices·94 affected·Jan 29, 2025
High RiskFDA
Pentax Of America Inc
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the low...
Medical Devices·138 affected·Jan 29, 2025
High RiskFDA
Trong Food International
Madras Curry Powder sold in 3 different package sizes. Recall has been expanded to include ALL LOTS. CA RI NI AN DO "KIM TU THAP", NET W...
Food·0 affected·Jan 28, 2025
CriticalFDA
Freshpoint Central Florida, Inc.
Garden Salad 5 oz Lot # 6620223 Best By: 02.05, UPC 766375733300
Produce·18 affected·Jan 28, 2025
CriticalFDA
Ascent Consumer Products Inc.
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natur...
Inhaled / Nasal Drugs·4,176 affected·Jan 28, 2025
CriticalFDA
Ascent Consumer Products Inc.
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP...
Inhaled / Nasal Drugs·0 affected·Jan 28, 2025
CriticalFDA
Ascent Consumer Products Inc.
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All N...
Inhaled / Nasal Drugs·0 affected·Jan 28, 2025
High RiskFDA
Ge Medical Systems, Llc
Optima XR646 HD. X-Ray imaging system.
Medical Devices·3,149 affected·Jan 28, 2025
High RiskFDA
Ge Medical Systems, Llc
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Medical Devices·3,149 affected·Jan 28, 2025
High RiskFDA
Ge Medical Systems, Llc
Discovery XR656 HD. X-Ray imaging system.
Medical Devices·3,149 affected·Jan 28, 2025
CriticalFDA
New York Wholesale Group
ZAARAH HERBALS brand SHATAVARI POWDER; 100% ASPARAGUS RACEMOSUS; (Supports Female Reproductive System); Supreme Fine Powder 100g (3.5 oz)...
Food·1,584 affected·Jan 27, 2025
CriticalFDA
United Natural Trading Inc. Dba Woodstock Farms
Fresh Direct Dark Chocolate Pretzels 7oz, Bag. 12 bags per case.
Snacks & Candy·99 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations s...
Medical Implants·16 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide supo...
Medical Implants·19 affected·Jan 27, 2025
High RiskFDA
Dexcom, Inc.
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Diabetes Devices·0 affected·Jan 27, 2025
High RiskFDA
Merit Medical Systems, Inc.
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Medical Devices·40 affected·Jan 27, 2025
High RiskFDA
Dexcom, Inc.
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Diabetes Devices·0 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations s...
Medical Implants·48 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations s...
Medical Implants·19 affected·Jan 27, 2025
High RiskFDA
Hiossen Inc.
ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations su...
Medical Implants·19 affected·Jan 27, 2025
CriticalFDA
Amazon Retail Llc
ASIN B0CY2RDW5T, Amazon Fresh brand, Bake at Home Jumbo Sugar Cookie 30oz, product is frozen dough, and packaged in flexible plastic bag....
Bakery & Grains·192 affected·Jan 25, 2025
CriticalFDA
Amazon Retail Llc
ASIN B084PZ7K98, Amazon Fresh Jumbo Sugar Cookie, 27 oz (12 count), product is baked and packaged in flexible plastic bag. 4-day shelf li...
Bakery & Grains·269 affected·Jan 25, 2025
High RiskFDA
Remedyrepack Inc.
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged...
Oral Drugs·247 affected·Jan 24, 2025
High RiskFDA
Sky Packaging
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distrib...
Oral Drugs·0 affected·Jan 24, 2025
High RiskFDA
Sky Packaging
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, Ind...
Oral Drugs·0 affected·Jan 24, 2025
High RiskFDA
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Versi...
Medical Devices·1,850 affected·Jan 24, 2025
High RiskFDA
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product D...
Medical Devices·541 affected·Jan 24, 2025
High RiskFDA
Bridgewell Agribusiness Llc
5912MOD-CAU Pre-Blend, item #991819, is a dry blend. Ingredients consist of Tapioca Starch, Long Grain Rice Flour, Cheese Powder [Cheddar...
Dairy·792 affected·Jan 23, 2025
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs·118,104 affected·Jan 23, 2025
High RiskFDA
Carefusion 303, Inc.
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the ...
Medical Devices·242,098 affected·Jan 23, 2025
CriticalFDA
La Fiesta Food Products
La Fiesta PAN RAYADO SAZONADO Bread Crumbs Seasoned, NET WT 8 OZ. (227g), UPC# 032327000887
Bakery & Grains·520 affected·Jan 22, 2025
CriticalFDA
La Fiesta Food Products
La Fiesta PAN RAYADO Bread Crumbs, NET WT 8 OZ. (227g), UPC# 032327000886
Bakery & Grains·2,200 affected·Jan 22, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark P...
Oral Drugs·0 affected·Jan 22, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pha...
Oral Drugs·0 affected·Jan 22, 2025
High RiskFDA
D. Coluccio & Sons Inc.
COLUSSI CANTUCCINI CHOCOLATE DROPS COOKIES
Bakery & Grains·1,944 affected·Jan 21, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this pac...
Oral Drugs·82,281 affected·Jan 21, 2025
CriticalFDA
Provepharm Inc.
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Pro...
Injectable Drugs·24,640 affected·Jan 21, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa...
Oral Drugs·94,349 affected·Jan 21, 2025
High RiskFDA
Avkare
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Oral Drugs·341 affected·Jan 21, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa...
Oral Drugs·27,525 affected·Jan 21, 2025