FDA enforcement

FDA recalls

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

Able Groupe Inc — HiPP Dutch Stage 1 Combiotic Infant Milk FormulaClass I · 2021-08-08
Able Groupe Inc — HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk FormulaClass I · 2021-08-08
Able Groupe Inc — HiPP Dutch Stage 2 Combiotic Follow-on Milk FormulaClass II · 2021-08-08
Able Groupe Inc — HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Mil…Class II · 2021-08-08
Able Groupe Inc — HiPP German Stage 1 Combiotic Infant Milk FormulaClass I · 2021-08-08
Able Groupe Inc — HiPP German Stage 2 Combiotic Follow-on Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — Holle Bio Stage 1 Organic Infant Milk FormulaClass I · 2021-08-08
Able Groupe Inc — Holle Bio Stage PRE Organic Infant Milk FormulaClass I · 2021-08-08
Able Groupe Inc — Holle Bio Stage 2 Organic Follow-On Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — Holle Goat Stage 1 Organic Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — Holle Goat Stage 2 Organic Follow-On Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — Lebenswert Anfangsmilch Stage 1 Organic Infant Milk FormulaClass I · 2021-08-08
Able Groupe Inc — Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — Lebenswert Folgemilch Stage 3 Organic Toddler FormulaClass II · 2021-08-08
Able Groupe Inc — HiPP UK Stage 1 Combiotic First Infant Milk FormulaClass I · 2021-08-08
Able Groupe Inc — HiPP UK Stage 2 Combiotic Follow-On Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — Kendamil Organic Stage 1 First Infant Milk FormulaClass II · 2021-08-08
Able Groupe Inc — Kendamil Organic Stage 2 Follow on Milk FormulaClass II · 2021-08-08
Able Sales Company, Inc. — Tereos Wheat Gluten, Net Weight 50 lbs, Distributed by Meelunie, Prod…Class III · 2022-04-05
Abrams Royal Pharamacy — MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dall…Class I · 2013-12-19
Abrams Royal Pharamacy — All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharm…Class II · 2013-12-19
Abrams Royal Pharmacy — Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 m…Class I · 2013-05-31
Abrams Royal Pharmacy — Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL…Class I · 2013-04-19
Abrams Royal Pharmacy — Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg …Class I · 2013-05-13
Abrams Royal Pharmacy II, LLC — CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, …Class III · 2015-06-23
Absonutrix — Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bottle Supple…Class III · 2018-06-11
Absorb Health LLC — Absorb Health Advanced Joint Relief Joint Health; 510mg; 90 CAPSULES;…Class II · 2020-04-15
Abundant Foods, LLC — Abundant Foods Good For You Kale Broccoli Salad, Net Weight: 5.0 lbs.…Class I · 2019-11-04
AC Creamery — Manila Sky Purple Yumm Ice Cream 16 oz.Class I · 2016-11-02
AC Culinary Group LLC — Label reads in part as: "EL ISLE¿O***SOFRITO GOURMET CON SAZON Y ACHI…Class II · 2016-06-30
AC Culinary Group LLC. — Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NET…Class II · 2019-11-12
AC Culinary Group LLC. — Chef Pineiro's Sofrito con Albahaca, with Basil, NET WT./PESO NETO 12…Class II · 2019-11-12
AC Culinary Group LLC. — Chef Pineiro's Ajo con Cilantro, with Coriander, NET WT./PESO NETO 8 …Class II · 2019-11-12
AC Culinary Group LLC. — Chef Pineiro's Ajo con Albahaca, with Basil, NET WT./PESO NETO 8 oz (…Class II · 2019-11-12
Accelerate Diagnostics Inc — Accelerate PhenoTest BC kit REF 10101018Class II · 2022-10-17
Accelerate Diagnostics Inc — Accelerate PhenoTest BC kit REF 10102018Class II · 2022-10-17
Accelerate Diagnostics Inc — Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 …Class II · 2017-03-13
Accelerate Diagnostics Inc — Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the lab…Class II · 2018-03-14
Accelerated Care Plus Corporation — Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, …Class II · 2013-06-12
Accelerated Care Plus Corporation — Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 m…Class I · 2021-08-25
Access Scientific Inc — POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no…Class II · 2013-08-16
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quic…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alter…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 1…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 1…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 1…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 1…Class II · 2020-04-23
Access Scientific LLC — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8…Class II · 2020-04-23
Access Scientific LLC — POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended…Class III · 2020-06-15
Access Vascular, Inc — HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model N…Class II · 2023-08-31
Access Vascular, Inc — HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number …Class II · 2023-08-31
Access Vascular, Inc — HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002Class II · 2022-12-16
Access Vascular, Inc — HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number …Class II · 2022-12-16
Access Vascular, Inc — HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number…Class II · 2022-12-16
Access Vascular, Inc — HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short …Class II · 2022-12-22
Access Vascular, Inc — HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short t…Class II · 2022-12-22
Access Vascular, Inc — HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Numbe…Class II · 2023-03-03
Access Vascular, Inc. — Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142,…Class II · 2021-02-24
AccessClosure, Inc., A Cardinal Health Company — The PAXWIRE Occlusion Balloon System consists of an occlusion cathete…Class II · 2016-10-06
AccessClosure, Inc., A Cardinal Health Company — 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Pro…Class II · 2016-07-13
Acclarent, Inc. — TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when us…Class II · 2023-09-21
Acclarent, Inc. — TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, RE…Class II · 2021-11-12
Acclarent, Inc. — TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877Class II · 2019-03-06
Acclarent, Inc. — TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884Class II · 2019-03-06
Acclarent, Inc. — TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891Class II · 2019-03-06
Acclarent, Inc. — RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. P…Class III · 2015-04-28
Acclarent, Inc. — Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume …Class II · 2013-01-11
Acclarent, Inc. — Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume …Class II · 2013-01-11
Acclarent, Inc. — Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volum…Class II · 2013-01-11
Acclarent, Inc. — Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume…Class II · 2013-01-11
Acclarent, Inc. — Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume…Class II · 2013-01-11
Acclarent, Inc. — Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume…Class II · 2013-01-11
Acclarent, Inc. — Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume…Class II · 2013-01-11
Accora Inc — Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair…Class II · 2021-06-21
ACCORD BIOPHARMA INC — IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx onl…Class II · 2026-06-10
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per …Class II · 2025-09-16
ACCORD HEALTHCARE, INC. — Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 m…Class II · 2024-10-01
ACCORD HEALTHCARE, INC. — Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 167…Class II · 2024-10-10
ACCORD HEALTHCARE, INC. — Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16…Class II · 2024-10-10
ACCORD HEALTHCARE, INC. — Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16…Class II · 2024-10-10
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bott…Class II · 2024-11-08
Accord Healthcare, Inc. — Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Man…Class I · 2022-11-29
Accord Healthcare, Inc. — Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactu…Class II · 2023-01-12
Accord Healthcare, Inc. — Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Singl…Class III · 2021-01-28
Accord Healthcare, Inc. — Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bot…Class II · 2023-02-07
Accord Healthcare, Inc. — Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottl…Class II · 2023-02-07
Accord Healthcare, Inc. — Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bott…Class II · 2023-02-07
Accord Healthcare, Inc. — Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bot…Class II · 2023-02-07
Accord Healthcare, Inc. — Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bo…Class II · 2023-02-07
Accord Healthcare, Inc. — Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 167…Class II · 2023-02-07
Accord Healthcare, Inc. — Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 …Class II · 2023-02-07
Accord Healthcare, Inc. — Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 T…Class II · 2023-02-07
Accord Healthcare, Inc. — Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Ta…Class II · 2023-02-07
Accord Healthcare, Inc. — Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Ta…Class II · 2023-02-07