Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
www.fda.gov →Official Site

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68,659 recalls
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, ...
Oral Drugs·6,925 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Mul...
Topical Drugs·40 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multi...
Oral Drugs·418 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-fil...
Injectable Drugs·749 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Her...
Injectable Drugs·30 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Conta...
Oral Drugs·353 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-f...
Injectable Drugs·1,825 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syri...
Injectable Drugs·2,568 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topic...
Oral Drugs·221 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colc...
Topical Drugs·56 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Us...
Topical Drugs·2,463 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edg...
Injectable Drugs·4,465 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercule...
Injectable Drugs·160 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular...
Injectable Drugs·1,720 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 ...
Oral Drugs·440 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topica...
Topical Drugs·154 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic U...
Topical Drugs·363 affected·Dec 6, 2021
High RiskFDA
Medique Products
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count...
Oral Drugs·3,260,400 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules ...
Injectable Drugs·309 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colches...
Drugs·860 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single U...
Topical Drugs·2,562 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colc...
Injectable Drugs·3,747 affected·Dec 6, 2021
High RiskFDA
Organics Corporation Of America Dba Ambix Laboratories
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadho...
Topical Drugs·4,214 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colches...
Topical Drugs·1,173 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit in...
Drugs·1,007 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per s...
Injectable Drugs·3,360 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per...
Injectable Drugs·1,202 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx On...
Injectable Drugs·3,930 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular In...
Injectable Drugs·0 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT...
Topical Drugs·74 affected·Dec 6, 2021
High RiskFDA
Medique Products
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactu...
Oral Drugs·6,639,838 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Col...
Inhaled / Nasal Drugs·231 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-...
Injectable Drugs·1,795 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Int...
Injectable Drugs·168 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Ot...
Oral Drugs·1,055 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colches...
Injectable Drugs·457 affected·Dec 6, 2021
High RiskFDA
Medique Products
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packe...
Oral Drugs·16,630,118 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Col...
Inhaled / Nasal Drugs·114 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC ...
Injectable Drugs·5,335 affected·Dec 6, 2021
CriticalFDA
Ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014...
Surgical Devices·71,260 affected·Dec 6, 2021
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, Part No. 08N53-002
Medical Devices·742 affected·Dec 6, 2021
CriticalFDA
Ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014"...
Surgical Devices·28,094 affected·Dec 6, 2021
CriticalFDA
Slayer Forever, Llc Dba Bubs Naturals
BUBS Naturals Fountain of Youth Formula; Collagen Protein; Support for Hair, Skin & Nails; Biotin, Antioxidant, Vitamin C; Maqui Berry Ne...
Produce·12,774 affected·Dec 3, 2021
RecallFDA
Dental Alliance Holdings Llc
CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured...
Oral Drugs·3 affected·Dec 3, 2021
RecallFDA
Dental Alliance Holdings Llc
CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205...
Oral Drugs·8 affected·Dec 3, 2021
RecallFDA
Akorn, Inc.
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- ND...
Oral Drugs·10,836 affected·Dec 3, 2021
RecallFDA
Dental Alliance Holdings Llc
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61...
Oral Drugs·360 affected·Dec 3, 2021
RecallFDA
Akorn, Inc.
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc.,...
Oral Drugs·8,184 affected·Dec 3, 2021