FDA enforcement

FDA recalls

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

Advanced Pharma Inc. — Dexmedetomidine HCl all strengths, all dosage forms and all packaging…Class II · 2017-02-22
Advanced Pharma Inc. — Cardioplegic Solution Maintenance all strengths, all dosage forms and…Class II · 2017-02-22
Advanced Pharma Inc. — Magnesium Sulfate all strengths, all dosage forms and all packaging, …Class II · 2017-02-22
Advanced Pharma Inc. — Potassium Phosphate all strengths, all dosage forms and all packaging…Class II · 2017-02-22
Advanced Pharma Inc. — Sodium Phosphate all strengths, all dosage forms and all packaging, R…Class II · 2017-02-22
Advanced Pharma Inc. — Sodium Citrate all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms…Class II · 2017-02-22
Advanced Pharma Inc. — Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms…Class II · 2017-02-22
Advanced Pharma Inc. — fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg…Class II · 2018-06-20
Advanced Pharma Inc. — QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 m…Class II · 2017-06-22
Advanced Pharma Inc. — Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmo…Class II · 2017-06-22
Advanced Pharma Inc. — Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmo…Class II · 2017-06-22
Advanced Pharma Inc. — Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmo…Class II · 2017-06-22
Advanced Pharma Inc. — HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable So…Class II · 2019-03-13
Advanced Pharma Inc. — fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chl…Class II · 2019-03-13
Advanced Pharma Inc. — fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Ch…Class II · 2019-03-13
Advanced Pharma Inc. — Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, M…Class II · 2019-03-13
Advanced Pharma Inc. — Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectabl…Class II · 2019-03-13
Advanced Pharma Inc. — Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile…Class II · 2019-03-13
Advanced Pharma Inc. — Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectab…Class II · 2019-03-13
Advanced Pharma Inc. — Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable …Class II · 2019-03-13
Advanced Pharma Inc. — Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), …Class II · 2019-03-13
Advanced Pharma Inc. — Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL …Class II · 2019-03-13
Advanced Pharma Inc. — 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL …Class II · 2019-03-13
Advanced Pharma Inc. — 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL…Class II · 2019-03-13
Advanced Pharma Inc. — Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectab…Class II · 2019-03-13
Advanced Pharma Inc. — Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Steri…Class II · 2019-03-13
Advanced Pharma Inc. — Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, I…Class II · 2019-03-13
Advanced Pharma Inc. — Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,0…Class II · 2019-03-13
Advanced Pharma Inc. — Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Inje…Class II · 2019-03-13
Advanced Pharma Inc. — Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine S…Class II · 2019-03-13
Advanced Pharma Inc. — Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Inject…Class II · 2019-03-13
Advanced Pharma Inc. — HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 …Class II · 2019-04-26
Advanced Pharmaceutical Technology, Inc. — TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, …Class II · 2025-10-03
Advanced Pharmaceutical Technology, Inc. — TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), O…Class II · 2025-05-30
Advanced Photonic Systems, LLC — Ultraslim. These include all products labeled as UltraSlim, Luxurian,…Class II · 2014-05-06
Advanced Photonic Systems, LLC — Luxurian. These include all products labeled as UltraSlim, Luxurian, …Class II · 2014-05-06
Advanced Photonic Systems, LLC — Photonica Light Modulator. These include all products labeled as Ultr…Class II · 2014-05-06
Advanced Physician Solutions, Inc. — CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTAB…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, A…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanc…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanc…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, A…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding P…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJ…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTA…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTA…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Ad…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compou…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJE…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Ad…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced C…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Adv…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanc…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Com…Class II · 2015-05-18
Advanced Physician Solutions, Inc. — ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABL…Class II · 2015-05-18
Advanced Research Medical, LLC — ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Fle…Class II · 2023-03-14
Advanced Spice & Trading, Inc. — Ground Cinnamon 2% (CASSIA) packaged in 50 pound bagClass I · 2020-09-22
Advanced Sterilization Products — STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 20…Class II · 2013-09-18
Advanced Sterilization Products — STERRAD 100NX Cassettes The STERRAD Sterilization System is a low …Class II · 2013-09-18
Advanced Sterilization Products — Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moi…Class II · 2013-10-18
Advanced Sterilization Products — STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization Syst…Class II · 2013-11-11
Advanced Sterilization Products — STERRAD NX, Product Code: 10033 The STERRAD Steri lization System …Class II · 2013-11-11
Advanced Sterilization Products — STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, pro…Class III · 2013-10-03
Advanced Sterilization Products — STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. …Class II · 2012-10-03
Advanced Sterilization Products — STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intend…Class II · 2013-11-26
Advanced Sterilization Products — STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations sys…Class II · 2012-09-20
Advanced Sterilization Products — STERRAD NX Sterilization System, Product Code: 10033 The STERRAD N…Class II · 2013-12-16
Advanced Sterilization Products — STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 …Class II · 2013-12-16
Advanced Sterilization Products — STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 1…Class II · 2013-12-16
Advanced Sterilization Products — STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on …Class II · 2014-11-04
Advanced Sterilization Products — STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used o…Class II · 2014-11-04
Advanced Sterilization Products — STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on …Class II · 2014-11-04
Advanced Sterilization Products — STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on S…Class II · 2014-11-04
Advanced Sterilization Products — STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used o…Class II · 2014-11-04
Advanced Sterilization Products — EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: …Class II · 2016-09-27
Advanced Sterilization Products — STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite…Class II · 2012-03-13
Advanced Sterilization Products — STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The …Class II · 2013-03-22
Advanced Sterilization Products — STERRAD 200 Sterilization System, P/N 10201 Product Usage: The ST…Class II · 2013-03-22
Advanced Sterilization Products — EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed…Class II · 2013-03-22
Advanced Sterilization Products — EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Desig…Class II · 2013-03-28
Advanced Sterilization Products — STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESU…Class II · 2013-04-22
Advanced Sterilization Products — STERRAD NX Sterilization System, Product Code: 10033, 10033-002Class II · 2017-01-09
Advanced Sterilization Products — Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425Class II · 2014-12-24
Advanced Sterilization Products — EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. …Class II · 2015-05-11
Advanced Sterilization Products — EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004…Class II · 2015-05-11
Advanced Sterilization Products — STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in ca…Class II · 2012-06-28
Advanced Sterilization Products — STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Steriliza…Class II · 2013-07-25
Advanced Sterilization Products — CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.5…Class II · 2012-06-01
Advanced Sterilization Products — STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRA…Class III · 2012-06-19
Advanced Sterilization Products — STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD …Class III · 2012-06-19
Advanced Sterilization Products — Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX …Class II · 2015-07-17
Advanced Sterilization Products — CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266Class II · 2015-07-27
Advanced Sterilization Products — CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant fo…Class II · 2015-08-10
Advandx Inc — AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture I…Class II · 2012-09-14
Advandx Inc — AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture I…Class II · 2012-09-14
Advandx Inc — AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. I…Class II · 2014-07-04
AdvanDx, Inc. — AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the ide…Class III · 2013-12-11
Advantage Health Matters Inc. — Organic traditions brand JUMBO PUMPKIN SEEDS; 227 g; 8 oz; Packaged a…Class I · 2025-05-07
Advantice Health — Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY cani…Class III · 2019-04-25