FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

Accuray Incorporated — TomoTherapy Treatment Delivery System with iDMS - Product Usage: used…Class II · 2020-12-10
Accuray Incorporated — Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated …Class II · 2014-01-13
Accuray Incorporated — CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radi…Class II · 2016-12-06
Accuray Incorporated — CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife S…Class II · 2024-12-23
Accuray Incorporated — Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery Sys…Class II · 2013-03-19
Accuray Incorporated — RoboCouch Patient Positioning System Product Usage: is intended…Class II · 2013-03-27
Accuray Incorporated — CyberKnife Treatment Delivery System - Product Usage: indicated for i…Class II · 2021-02-26
Accuray Incorporated — CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delive…Class II · 2018-04-10
Accuray Incorporated — CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x R…Class II · 2018-04-10
Accuray Incorporated — Upper roller bracket (part number 1088370) for the Gen2 gantry enclos…Class II · 2023-08-03
Accuray Incorporated — Cyberknife Treatment Deliver System equipped with the Xchange Robotic…Class II · 2026-06-16
Accuray Incorporated — Cyberknife Treatment Deliver System equipped with the Xchange Robotic…Class II · 2026-06-16
Accuray Incorporated — Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Pro…Class II · 2018-08-31
Accure Acne, Inc — Accure Laser System, Model: PFMS00004Class II · 2023-12-06
Accuro Medical Product LLC — Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; …Class II · 2012-08-31
Accutron Inc — Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, …Class I · 2012-04-29
Accutron Inc — Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13…Class I · 2012-04-29
Accutron Inc — CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: …Class I · 2012-04-29
Accutron Inc — Newport Portable Package, Model #50000, Serial # 13591, 13592, 1360…Class I · 2012-04-29
Ace Surgical Supply Co., Inc. — Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distri…Class II · 2017-10-24
Ace Surgical Supply Co., Inc. — NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodonta…Class II · 2022-02-02
Ace Surgical Supply Co., Inc. — Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Use…Class II · 2018-03-28
Ace Surgical Supply Co., Inc. — INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm …Class II · 2017-02-22
ACell, Inc — Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lo…Class II · 2019-02-14
ACell, Inc — Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lo…Class II · 2019-02-14
Acella Pharmaceuticals, LLC — Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, …Class II · 2025-09-29
Acella Pharmaceuticals, LLC — NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottle…Class I · 2020-09-17
Acella Pharmaceuticals, LLC — NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottl…Class I · 2020-09-17
Acella Pharmaceuticals, LLC — Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packag…Class III · 2022-11-14
Acella Pharmaceuticals, LLC — Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packa…Class III · 2022-11-14
Acella Pharmaceuticals, LLC — Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (6…Class III · 2022-11-14
Acella Pharmaceuticals, LLC — NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) …Class I · 2021-04-29
Acella Pharmaceuticals, LLC — NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) …Class I · 2021-04-29
Acella Pharmaceuticals, LLC — NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles,…Class I · 2021-04-29
Acella Pharmaceuticals, LLC — NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bott…Class I · 2021-04-29
Acella Pharmaceuticals, LLC — NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) …Class I · 2021-04-29
Acella Pharmaceuticals, LLC — Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g…Class III · 2024-04-24
Acella Pharmaceuticals, LLC — NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) …Class II · 2026-04-20
Acella Pharmaceuticals, LLC — NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bot…Class I · 2020-05-22
Acella Pharmaceuticals, LLC — NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottl…Class I · 2020-05-22
Acella Pharmaceuticals, LLC — NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count…Class I · 2020-05-22
Acera Surgical Inc — Restrata, Part Number RWM1-2X2Class II · 2022-03-21
Aceto US, L.L.C — a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg…Class III · 2025-06-24
Ach Food Companies Inc — Salad topping labeled under the following brand names: (Product 1) …Class I · 2016-06-02
Achdut — Organic Tahini sold under the following brand names: Pepperwood organ…Class I · 2018-11-23
Achdut — Raw Tahini sold under the following brand names: Baron's raw Tahini, …Class I · 2018-11-23
Achdut — Seasoned Tahini sold under the following brand name: Galil Seasoned T…Class I · 2018-11-23
Achdut — Tahini sold under the following brand names: Baron's Tahini double p…Class I · 2018-11-23
Acist Medical Systems — ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) a…Class II · 2015-12-21
Acist Medical Systems — ACIST Medical Systems Inc. The ACIST Angiographic Injection System…Class II · 2013-03-15
Acist Medical Systems — ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intrava…Class I · 2021-01-22
ACME FOOD SALES INC — O Organics Tahini is 100% organic ground slightly roasted sesame seed…Class II · 2020-07-21
Acme Food Sales, Inc — Canned mandarin oranges labeled in part: "WESTERN FAMILY Choice Selec…Class III · 2012-11-30
Acme Smoked Fish Corp. — KIRKLAND Signature Smoked Salmon NET WT 340 g (12 oz) MUST KEEP REFRI…Class I · 2024-10-22
Acme Smoked Fish Corp. — SMOKED NOVA Salmon, NET WT 4 oz (113g). Product is held in vacuum pa…Class I · 2014-11-20
ACME UNITED CORPORATION — Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-…Class II · 2025-09-23
ACME UNITED CORPORATION — First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%…Class II · 2026-01-20
ACME UNITED CORPORATION — First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%…Class II · 2026-01-20
ACME UNITED CORPORATION — Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Pac…Class II · 2026-01-20
ACME UNITED CORPORATION — First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%)…Class II · 2026-01-20
ACME UNITED CORPORATION — 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Pie…Class II · 2026-01-20
ACME UNITED CORPORATION — Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), …Class II · 2026-01-20
ACME UNITED CORPORATION — Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 to…Class II · 2026-01-20
ACME UNITED CORPORATION — Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 w…Class II · 2026-01-20
ACME UNITED CORPORATION — Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 …Class II · 2026-01-20
ACME UNITED CORPORATION — BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000…Class II · 2026-01-20
ACME UNITED CORPORATION — Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chlo…Class II · 2026-01-20
ACME UNITED CORPORATION — Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%)…Class II · 2026-01-20
ACME UNITED CORPORATION — Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case…Class II · 2026-01-20
ACME UNITED CORPORATION — Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towel…Class II · 2026-01-20
ACME UNITED CORPORATION — WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7…Class II · 2026-01-20
ACME UNITED CORPORATION — Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, A…Class II · 2026-01-20
ACME UNITED CORPORATION — Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes …Class II · 2026-01-20
ACME UNITED CORPORATION — Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100…Class II · 2026-01-20
ACME UNITED CORPORATION — Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7…Class II · 2026-01-20
ACME UNITED CORPORATION — Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzal…Class II · 2026-01-20
ACME UNITED CORPORATION — Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured …Class II · 2026-01-20
Acon Biotech (Hangzhou) Co., Ltd. — Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE markedClass II · 2022-01-09
Acon Laboratories, Inc. — Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow …Class III · 2015-06-17
Acorn Stairlifts Inc — Acorn 180 Curved StairliftClass II · 2016-02-17
Acorn Stairlifts, Inc — Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and A…Class II · 2016-04-20
ACP Nimble Buyer, Inc. — Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: …Class III · 2019-02-07
Actavis — Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for top…Class III · 2014-02-07
Actavis — Fentanyl Transdermal System, 100 mcg/h, each transdermal system conta…Class II · 2012-07-11
Actavis — Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3…Class III · 2013-06-03
Actavis Elizabeth LLC — NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactur…Class III · 2016-10-06
Actavis Elizabeth LLC — Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles…Class II · 2013-10-09
Actavis Elizabeth LLC — Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle…Class II · 2014-12-15
Actavis Elizabeth LLC — Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, M…Class II · 2014-12-15
Actavis Elizabeth LLC — Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle…Class II · 2014-12-15
Actavis Elizabeth LLC — Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count …Class II · 2015-02-10
Actavis Elizabeth LLC — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamin…Class II · 2016-02-16
Actavis Elizabeth LLC — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamin…Class II · 2016-02-16
Actavis Elizabeth LLC — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamin…Class II · 2016-02-16
Actavis Elizabeth LLC — Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamin…Class II · 2016-02-16
Actavis Elizabeth LLC — Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Eli…Class II · 2013-11-06
Actavis Elizabeth LLC — Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per …Class II · 2014-02-04
Actavis Elizabeth LLC — Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manuf…Class II · 2014-02-10
Actavis Elizabeth LLC — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dext…Class III · 2013-02-13
Actavis Inc — Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack,…Class II · 2014-08-25