FDA enforcement

FDA recalls

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

Actavis Inc — Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack,…Class II · 2014-08-25
Actavis Inc — Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister …Class II · 2015-02-12
Actavis Inc — Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister …Class II · 2015-02-12
Actavis Inc — Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), …Class III · 2017-01-12
Actavis Inc — Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only,…Class II · 2017-01-30
Actavis Inc — Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bot…Class III · 2017-02-07
Actavis Inc — BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, …Class III · 2013-11-15
Actavis Inc — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg…Class II · 2013-03-22
Actavis Inc — Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose …Class II · 2013-12-09
Actavis Inc — Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets U…Class III · 2015-06-04
Actavis Inc — Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 1…Class II · 2014-05-16
Actavis Inc — Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count…Class II · 2016-07-11
Actavis Inc — Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, …Class II · 2016-06-30
Actavis Inc — Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx O…Class III · 2016-08-02
Actavis Inc — Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, …Class III · 2016-08-02
Actavis Inc — BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-cou…Class III · 2013-07-31
Actavis Laboratories — Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By:…Class III · 2015-04-14
Actavis Laboratories, FL, Inc. — Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count b…Class II · 2015-09-25
Actavis Laboratories, FL, Inc. — Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactur…Class III · 2016-08-30
Actavis Laboratories, FL, Inc. — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 …Class II · 2014-09-26
Actavis Laboratories, FL, Inc. — Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day …Class III · 2015-03-26
Actavis Laboratories, FL, Inc. — Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manu…Class III · 2015-06-23
Actavis Laboratories, FL, Inc. — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 …Class II · 2014-04-24
Actavis Laboratories, FL, Inc. — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 …Class II · 2014-04-24
Actavis Mid Atlantic LLC — Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25m…Class III · 2012-08-14
Actavis Mid Atlantic LLC — Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine p…Class III · 2012-08-14
Actavis Pharma Inc — Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a…Class III · 2016-03-16
Actavis Pharmaceuticals — buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 ta…Class III · 2013-01-04
Actavis South Atlantic LLC — buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-coun…Class III · 2013-03-22
Actavis South Atlantic LLC — Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. M…Class II · 2013-05-15
Actavis South Atlantic LLC — buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-cou…Class III · 2013-08-21
Actelion Pharmaceuticals U.S., Inc. — Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Sin…Class III · 2013-01-16
ACTIM OY — Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test…Class II · 2023-11-23
ActiPharma, Inc. — ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per c…Class III · 2023-09-28
Activbody, Inc. — Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 Use…Class II · 2021-11-30
Activbody, Inc. — activforce 2 package labeling: Model: Activ5-M R 201-200563Class II · 2021-11-30
AcuFocus, Inc. — KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 …Class II · 2016-02-11
Acuity Specialty Products, Inc. — Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511),…Class II · 2025-09-29
Acuity Specialty Products, Inc. — AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufac…Class II · 2025-09-29
Acuity Surgical Devices, LLC — A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A…Class II · 2019-01-07
Acuity Surgical Devices, LLC — A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A…Class II · 2019-01-07
Acumed LLC — RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL23…Class II · 2023-11-27
Acumed LLC — Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion …Class II · 2022-11-29
Acumed LLC — Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ -…Class II · 2022-11-29
Acumed LLC — AcuTwist Acutrak Compression Screws Part Number/Part Description: A…Class II · 2022-11-29
Acumed LLC — Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0…Class II · 2022-11-29
Acumed LLC — 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010Class II · 2022-03-09
Acumed LLC — 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012Class II · 2022-03-09
Acumed LLC — OPT Croutons is a synthetic bone substitute designed for the repair o…Class II · 2016-12-05
Acumed LLC — 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates fo…Class II · 2017-01-19
Acumed LLC — Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the fol…Class II · 2023-12-19
Acumed LLC — .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-…Class II · 2017-02-17
Acumed LLC — The Osteo-Clage System consists of stainless steel cable/sleeves and …Class II · 2014-03-26
Acumed LLC — The Acumed Tension Band Pin is a fixation pin which is .0625" in diam…Class II · 2014-03-26
Acumed LLC — The Acumed Slide-Loc Anatomic Radial Head System is intended for use …Class II · 2017-04-20
Acumed LLC — Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm …Class II · 2026-05-28
Acumedia Manufacturers, Inc. — Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated cultu…Class III · 2018-08-02
Acumedia Manufacturers, Inc. — Campylobacter Blood Free Selective Medium, PN 7527A Used with cef…Class III · 2018-08-02
Acumedia Manufacturers, Inc. — Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizesClass II · 2016-04-22
Acumedia Manufacturers, Inc. — Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 …Class III · 2016-08-08
Acumedia Manufacturers, Inc. — Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutr…Class III · 2016-03-23
Acumedia Manufacturers, Inc. — Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract…Class III · 2015-09-11
Acumedia Manufacturers, Inc. — Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar fo…Class III · 2016-09-25
Acumedia Manufacturers, Inc. — Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Suppleme…Class II · 2015-11-30
ACUTE Innovations, LLC — The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is compri…Class II · 2013-10-30
Acutus Medical Inc — Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dila…Class II · 2020-02-25
Acutus Medical Inc — Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX I…Class II · 2020-02-25
Acutus Medical Inc — Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dil…Class II · 2020-02-25
Acutus Medical Inc — Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX In…Class II · 2020-02-25
Ad-Tech Medical Instrument Corporation — Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3…Class II · 2014-10-08
Ad-Tech Medical Instrument Corporation — AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact …Class II · 2024-09-19
Ad-Tech Medical Instrument Corporation — AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact …Class II · 2024-09-19
Ad-Tech Medical Instrument Corporation — AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact …Class II · 2024-09-19
Ad-Tech Medical Instrument Corporation — Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode…Class I · 2012-12-18
Ad-Tech Medical Instrument Corporation — Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH …Class II · 2016-03-29
Ad-Tech Medical Instrument Corporation — Disposable Drill Kit which includes two drill bits, two drill stops, …Class II · 2017-12-20
Ad-Tech Medical Instrument Corporation — LSB Style Anchor Bolt. Labeled with the following parts: 13mm a…Class II · 2019-06-18
Ad-Tech Medical Instrument Corporation — AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech …Class II · 2019-04-16
Ad-Tech Medical Instrument Corporation — Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdu…Class II · 2019-06-18
Ad-Tech Medical Instrument Corporation — Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth E…Class II · 2019-06-18
Ad-Tech Medical Instrument Corporation — Skull Anchor BoltsClass II · 2019-06-18
Ad-Tech Medical Instrument Corporation — Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the pu…Class II · 2021-08-09
Ad-Tech Medical Instrument Corporation — Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for t…Class II · 2021-08-09
Ad-Tech Medical Instrument Corporation — Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of…Class II · 2021-08-09
Ad-Tech Medical Instrument Corporation — AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-09…Class II · 2018-05-02
Ad-Tech Medical Instrument Corporation — AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) R…Class II · 2019-08-27
Adam Bros. Farming, Inc. — Adam Bros. Family Farms Red Leaf Lettuce 24 heads per carton Adam…Class I · 2018-12-13
Adam Bros. Farming, Inc. — Adam Bros. Family Farms Green Leaf Lettuce; 24 heads per caseClass I · 2018-12-13
Adam Bros. Farming, Inc. — Adam Bros. Family Farms Cauliflower; Sold in cases with 9, 12, 16 or…Class I · 2018-12-13
Adam's Polishes LLC — Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v…Class I · 2022-11-05
Adam's Polishes LLC — Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v…Class II · 2022-11-05
Adamis Pharmaceuticals Corporation — SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre…Class I · 2022-03-21
Adamis Pharmaceuticals Corporation — SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pr…Class I · 2022-03-21
Adams Extract & Spice LLC — Adams Reserve, Fajita Grilling Rub 5.7 oz. Bottle Item Code: 04544, 1…Class II · 2018-02-28
Adams Extract & Spice LLC — Adams Reserve Sweet & Spicy Seafood Salmon NEY WT 2.5 OZ (73g) UPC co…Class II · 2020-06-02
Adams Extract & Spice LLC — Adams Pantry Basics Chili Powder Net Wt. 2.82 oz (80 g) UPC: 04131301…Class I · 2014-12-26
Adams Extract & Spice LLC — Adams Pantry Basics Ground Cumin Net Wt. 2.82 oz (80 g) UPC: 04131301…Class I · 2014-12-26
Adams Extract & Spice LLC — Adams Pantry Basics Saver Size Menudo Seasoning Net Wt. 18 oz. (511 g…Class I · 2014-12-26
Adams Extract & Spice LLC — Adams Jamaican Jerk Seasoning Net Wt. 5.26 oz. (149 g) UPC: 041313023…Class I · 2014-12-26
Adams Extract & Spice LLC — Adams Brisket Rub Net Wt. 13.47 oz (382 g) UPC: 041313024338; Adams B…Class I · 2014-12-26