FDA enforcement

FDA recalls

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

Advanced Food Concepts — GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Sa…Class III · 2018-07-18
Advanced Food Concepts — GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Wi…Class III · 2018-07-18
Advanced Fresh Concepts Corp — Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp; Tray +0.498 poun…Class II · 2020-03-12
Advanced Fresh Concepts Corp — AFC Edamame Soybeans in Pods, 8 oz , refrigerated, in cardboard conta…Class I · 2017-03-13
Advanced Instruments, LLC — GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Count…Class II · 2018-02-07
Advanced Instruments, LLC — OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses…Class II · 2024-03-11
Advanced Medical Solutions Ltd. — Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium …Class II · 2024-10-01
Advanced Medical Solutions Ltd. — McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indica…Class II · 2024-10-01
Advanced Medical Solutions Ltd. — MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP…Class II · 2024-10-01
Advanced Medical Solutions Ltd. — ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (pr…Class II · 2015-01-15
Advanced Medical Solutions Ltd. — ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary …Class II · 2015-01-15
Advanced Neuromodulation Systems Inc. — The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, recha…Class II · 2012-09-04
Advanced Neuromodulation Systems Inc. — Advanced Neuromodulation Systems, Brio DBS System implantable neurost…Class II · 2012-03-28
Advanced Neuromodulation Systems Inc. — Eon Mini Neurostimulation (IPG) System (Model 3788); The product i…Class II · 2011-12-19
Advanced Neuromodulation Systems Inc. — Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed t…Class II · 2011-12-19
Advanced Neuromodulation Systems Inc. — The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-chann…Class II · 2011-12-19
Advanced Nutriceuticals, LLC — CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Me…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, …Class II · 2020-11-30
Advanced Nutriceuticals, LLC — PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicin…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Med…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Med…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecu…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular …Class II · 2020-11-30
Advanced Nutriceuticals, LLC — GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medici…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medici…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecu…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medici…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecul…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Mol…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicin…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medic…Class II · 2020-11-30
Advanced Nutriceuticals, LLC — Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Mo…Class II · 2020-11-30
Advanced Orthogonal Equipment, Incorporated — Advanced Orthogonal Percussion Adjusting Instrument Indicated for…Class II · 2013-03-06
Advanced Pharma Inc. — NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per…Class I · 2017-06-09
Advanced Pharma Inc. — NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 m…Class I · 2017-06-09
Advanced Pharma Inc. — NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg pe…Class I · 2017-06-09
Advanced Pharma Inc. — NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per…Class II · 2017-06-09
Advanced Pharma Inc. — NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 …Class II · 2017-06-09
Advanced Pharma Inc. — NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 m…Class II · 2017-06-09
Advanced Pharma Inc. — NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg pe…Class II · 2017-06-09
Advanced Pharma Inc. — Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injec…Class I · 2018-11-29
Advanced Pharma Inc. — HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.4…Class II · 2019-01-15
Advanced Pharma Inc. — Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0…Class II · 2019-02-06
Advanced Pharma Inc. — Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chlor…Class III · 2019-02-06
Advanced Pharma Inc. — Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chlor…Class III · 2019-02-06
Advanced Pharma Inc. — Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chlori…Class III · 2019-02-06
Advanced Pharma Inc. — MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chlo…Class I · 2018-01-05
Advanced Pharma Inc. — Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage for…Class II · 2017-02-22
Advanced Pharma Inc. — Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage for…Class II · 2017-02-22
Advanced Pharma Inc. — Lidocaine all strengths, all dosage forms and all packaging, Rx Only…Class II · 2017-02-22
Advanced Pharma Inc. — Nalbuphine all strengths, all dosage forms and all packaging, Rx Onl…Class II · 2017-02-22
Advanced Pharma Inc. — RECK PeriCapsular injection all strengths, all dosage forms and all p…Class II · 2017-02-22
Advanced Pharma Inc. — NOVA PeriCapsular injection all strengths, all dosage forms and all p…Class II · 2017-02-22
Advanced Pharma Inc. — Ofirmev (Acetaminophen) injection all strengths, all dosage forms and…Class II · 2017-02-22
Advanced Pharma Inc. — Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage form…Class II · 2017-02-22
Advanced Pharma Inc. — NICU STARTER TPN all strengths, all dosage forms and all packaging, R…Class II · 2017-02-22
Advanced Pharma Inc. — TPN Neonatal all strengths, all dosage forms and all packaging, Rx O…Class II · 2017-02-22
Advanced Pharma Inc. — Standard Starter TPN all strengths, all dosage forms and all packagin…Class II · 2017-02-22
Advanced Pharma Inc. — Early TPN (Neonatal) all strengths, all dosage forms and all packagin…Class II · 2017-02-22
Advanced Pharma Inc. — Early Baby TPN (Neonatal) all strengths, all dosage forms and all pac…Class II · 2017-02-22
Advanced Pharma Inc. — ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms a…Class II · 2017-02-22
Advanced Pharma Inc. — Sufentanil Citrate all strengths, all dosage forms and all packaging,…Class II · 2017-02-22
Advanced Pharma Inc. — Fentanyl Citrate all strengths, all dosage forms and all packaging, R…Class II · 2017-02-22
Advanced Pharma Inc. — Hydromorphone HCl all strengths, all dosage forms and all packaging, …Class II · 2017-02-22
Advanced Pharma Inc. — Meperidine HCl all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Morphine Sulfate all strengths, all dosage forms and all packaging, R…Class II · 2017-02-22
Advanced Pharma Inc. — Ketamine HCl all strengths, all dosage forms and all packaging, Rx O…Class II · 2017-02-22
Advanced Pharma Inc. — Midazolam HCl all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Lorazepam HCl all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Methohexital Sodium all strengths, all dosage forms and all packaging…Class II · 2017-02-22
Advanced Pharma Inc. — Cefazolin all strengths, all dosage forms and all packaging, Rx Only…Class II · 2017-02-22
Advanced Pharma Inc. — Vancomycin HCl all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Penicillin G Potassium all strengths, all dosage forms and all packag…Class II · 2017-02-22
Advanced Pharma Inc. — Gentamicin Sulfate all strengths, all dosage forms and all packaging,…Class II · 2017-02-22
Advanced Pharma Inc. — Oxytocin all strengths, all dosage forms and all packaging, Rx Only,…Class II · 2017-02-22
Advanced Pharma Inc. — Heparin sodium all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — 0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all…Class II · 2017-02-22
Advanced Pharma Inc. — Diltiazem HCl all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Phenylephrine HCl all strengths, all dosage forms and all packaging, …Class II · 2017-02-22
Advanced Pharma Inc. — Ephedrine Sulfate all strengths, all dosage forms and all packaging, …Class II · 2017-02-22
Advanced Pharma Inc. — Norepinephrine Bitartrate all strengths, all dosage forms and all pac…Class II · 2017-02-22
Advanced Pharma Inc. — Epinephrine HCl all strengths, all dosage forms and all packaging, Rx…Class II · 2017-02-22
Advanced Pharma Inc. — Calcium Gluconate all strengths, all dosage forms and all packaging, …Class II · 2017-02-22
Advanced Pharma Inc. — Amiodarone all strengths, all dosage forms and all packaging, Rx Only…Class II · 2017-02-22
Advanced Pharma Inc. — Succinylcholine Chloride all strengths, all dosage forms and all pack…Class II · 2017-02-22
Advanced Pharma Inc. — Adenosine all strengths, all dosage forms and all packaging, Rx Only,…Class II · 2017-02-22
Advanced Pharma Inc. — Nitroglycerin all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Nicardipine HCl all strengths, all dosage forms and all packaging, Rx…Class II · 2017-02-22
Advanced Pharma Inc. — Rocuronium Bromide all strengths, all dosage forms and all packaging,…Class II · 2017-02-22
Advanced Pharma Inc. — Labetalol HCl all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Esmolol HCl all strengths, all dosage forms and all packaging, Rx On…Class II · 2017-02-22
Advanced Pharma Inc. — Glycopyrrolate all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Neostigmine Methylsulfate all strengths, all dosage forms and all pac…Class II · 2017-02-22
Advanced Pharma Inc. — Atropine Sulfate all strengths, all dosage forms and all packaging, R…Class II · 2017-02-22
Advanced Pharma Inc. — Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths,…Class II · 2017-02-22
Advanced Pharma Inc. — Famotidine HCl all strengths, all dosage forms and all packaging, Rx …Class II · 2017-02-22
Advanced Pharma Inc. — Ondansetron HCl all strengths, all dosage forms and all packaging, Rx…Class II · 2017-02-22
Advanced Pharma Inc. — Bumetadine all strengths, all dosage forms and all packaging, Rx Onl…Class II · 2017-02-22
Advanced Pharma Inc. — Dexamethasone Sodium Phosphate all strengths, all dosage forms and al…Class II · 2017-02-22