FDA enforcement

FDA recalls

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

Accord Healthcare, Inc. — BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only…Class II · 2023-02-07
Accord Healthcare, Inc. — BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 1…Class II · 2023-02-07
Accord Healthcare, Inc. — BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle,…Class II · 2023-02-07
Accord Healthcare, Inc. — BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only,…Class II · 2023-02-07
Accord Healthcare, Inc. — BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, …Class II · 2023-02-07
Accord Healthcare, Inc. — Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bot…Class II · 2023-02-07
Accord Healthcare, Inc. — Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single…Class II · 2023-02-07
Accord Healthcare, Inc. — Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, …Class II · 2023-02-07
Accord Healthcare, Inc. — Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Ma…Class II · 2023-02-07
Accord Healthcare, Inc. — Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manuf…Class II · 2023-02-07
Accord Healthcare, Inc. — Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manuf…Class II · 2023-02-07
Accord Healthcare, Inc. — Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle…Class II · 2023-02-07
Accord Healthcare, Inc. — Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottl…Class II · 2023-02-07
Accord Healthcare, Inc. — Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottl…Class II · 2023-02-07
Accord Healthcare, Inc. — Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC…Class II · 2023-02-07
Accord Healthcare, Inc. — Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bot…Class II · 2023-02-07
Accord Healthcare, Inc. — Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufa…Class II · 2023-02-07
Accord Healthcare, Inc. — Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bott…Class II · 2023-02-07
Accord Healthcare, Inc. — Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bot…Class II · 2023-02-07
Accord Healthcare, Inc. — Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets N…Class II · 2023-02-07
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, R…Class II · 2025-04-10
Accord Healthcare, Inc. — Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bot…Class II · 2023-02-07
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx…Class II · 2025-04-10
Accord Healthcare, Inc. — Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 …Class II · 2023-02-07
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, R…Class II · 2025-04-10
Accord Healthcare, Inc. — Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Do…Class II · 2023-02-07
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx…Class II · 2025-04-10
Accord Healthcare, Inc. — Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dos…Class II · 2023-02-07
Accord Healthcare, Inc. — Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple D…Class II · 2023-02-07
Accord Healthcare, Inc. — Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-c…Class II · 2023-02-07
Accord Healthcare, Inc. — Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Sin…Class II · 2023-02-07
Accord Healthcare, Inc. — Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx …Class II · 2023-02-07
Accord Healthcare, Inc. — Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), R…Class II · 2023-02-07
Accord Healthcare, Inc. — Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count …Class II · 2023-02-07
Accord Healthcare, Inc. — Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count…Class II · 2023-02-07
Accord Healthcare, Inc. — Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count b…Class II · 2023-02-07
Accord Healthcare, Inc. — Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bo…Class II · 2023-02-07
Accord Healthcare, Inc. — Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle…Class II · 2023-02-07
Accord Healthcare, Inc. — Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bo…Class II · 2023-02-07
Accord Healthcare, Inc. — Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottl…Class II · 2023-02-07
Accord Healthcare, Inc. — Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count table…Class II · 2023-02-07
Accord Healthcare, Inc. — Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottl…Class II · 2023-02-07
Accord Healthcare, Inc. — Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 …Class II · 2023-02-07
Accord Healthcare, Inc. — Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bot…Class II · 2023-02-07
Accord Healthcare, Inc. — Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle…Class II · 2023-02-07
Accord Healthcare, Inc. — Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bott…Class II · 2023-02-07
Accord Healthcare, Inc. — Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bot…Class II · 2023-02-07
Accord Healthcare, Inc. — Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton…Class II · 2023-02-07
Accord Healthcare, Inc. — Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufa…Class II · 2023-02-07
Accord Healthcare, Inc. — Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured fo…Class II · 2023-02-07
Accord Healthcare, Inc. — Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-co…Class II · 2023-02-07
Accord Healthcare, Inc. — Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manuf…Class II · 2023-02-07
Accord Healthcare, Inc. — Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Ma…Class II · 2023-02-07
Accord Healthcare, Inc. — Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Man…Class II · 2023-02-07
Accord Healthcare, Inc. — rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactu…Class II · 2023-02-07
Accord Healthcare, Inc. — rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactur…Class II · 2023-02-07
Accord Healthcare, Inc. — rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured…Class II · 2023-02-07
Accord Healthcare, Inc. — rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufacture…Class II · 2023-02-07
Accord Healthcare, Inc. — rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured…Class II · 2023-02-07
Accord Healthcare, Inc. — rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured …Class II · 2023-02-07
Accord Healthcare, Inc. — rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured …Class II · 2023-02-07
Accord Healthcare, Inc. — Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured fo…Class II · 2016-12-20
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle…Class II · 2025-06-20
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bott…Class II · 2025-06-20
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle,…Class II · 2025-06-20
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottl…Class II · 2025-06-20
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bot…Class II · 2025-06-20
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bott…Class II · 2025-06-20
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bot…Class II · 2025-06-20
Accord Healthcare, Inc. — Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML…Class III · 2023-03-29
Accord Healthcare, Inc. — Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL mul…Class III · 2024-06-18
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottle…Class II · 2026-06-08
Accord Healthcare, Inc. — Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL…Class II · 2023-07-03
Accord Healthcare, Inc. — Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manu…Class II · 2023-07-03
Accord Healthcare, Inc. — Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, …Class I · 2018-08-21
Accord Media, LLC — Ultra RenewClass II · 2017-12-04
Accord Media, LLC — Truth RenewClass II · 2017-12-04
Accord Media, LLC — Ultra Renew PlusClass II · 2017-12-04
Accord Media, LLC — Truth Renew PlusClass II · 2017-12-04
Accriva Diagnostics Inc., dba ITC, dba Accumetrics — Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catal…Class II · 2016-04-22
Accriva Diagnostics, Inc. — AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is …Class II · 2024-09-27
Accriva Diagnostics, Inc. — VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10…Class III · 2025-10-21
Accriva Diagnostics, Inc. — Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR…Class II · 2025-11-05
Accriva Diagnostics, Inc. — VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064Class II · 2024-12-02
Accriva Diagnostics, Inc. — The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 recept…Class II · 2022-03-30
Accriva Diagnostics, Inc. — directCHECK ACT-LR whole blood quality control, level 2 Model/Catalo…Class II · 2026-04-30
Accumetrics Inc — VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/…Class II · 2013-11-14
Accumetrics Inc — VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog N…Class II · 2014-02-13
Accumetrics Inc — VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Produ…Class II · 2012-02-06
Accumetrics Inc — VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y…Class II · 2012-02-06
Accupac, Inc. — Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% pot…Class II · 2021-05-13
Accuray Incorporated — CyberKnife Robotic Radiosurgery System with the first generation IRIS…Class II · 2014-10-31
Accuray Incorporated — Hi-Art(R) System, Model Number H-000-0003 Product Usage: The Tomo…Class II · 2017-11-17
Accuray Incorporated — TomoHD(R) System, Model Number 1018283 Product Usage: The TomoThe…Class II · 2017-11-17
Accuray Incorporated — TomoH(R) System, Model Number 1018284 Product Usage: The TomoTher…Class II · 2017-11-17
Accuray Incorporated — TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTh…Class II · 2017-11-17
Accuray Incorporated — CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems a…Class II · 2018-09-26
Accuray Incorporated — CyberKnife Robotic Radiosurgery System using software version 10.6; …Class II · 2016-11-22
Accuray Incorporated — CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic co…Class II · 2016-01-22
Accuray Incorporated — TomoTherapy Treatment System - Product Usage: used as an integrated s…Class II · 2020-12-10