Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4551–4575 of 18005

HighFDA (Drugs)·D-0417-2022·2022-02-02
Phenylephrine HCl Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma is recalling approximately 5,335 syringes of Phenylephrine HCl Sterile Solution for Injection nationwide due to lack of assurance of sterility. The product may not meet sterility requirements for safe use.
Product
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0423-2022·2022-02-02
Betadine Sterile Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma is recalling Betadine sterile ophthalmic solution syringes due to lack of assurance of sterility. The affected product is a preservative-free, single-use ophthalmic solution distributed nationwide.
Product
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2022·2022-02-02
Gemcitabine Intravesical Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling approximately 627 syringes of Gemcitabine Sterile Intravesical Solution nationwide because the manufacturer cannot guarantee the product is sterile. The recalled batches were distributed between December 2021 and February 2022.
Product
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0439-2022·2022-02-02
Drug Recall: Profound Dental Gel CGMP Deviations
Edge Pharma is voluntarily recalling 353 jars of Profound Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0457-2022·2022-02-02
CariFree CTx36 Kit recalled for subpotent fluoride content
Dental Alliance Holdings LLC is recalling the CTx36 Kit because it contains less sodium fluoride than stated on the product label. Affected patients should contact their dentist.
Product
CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0449-2022·2022-02-02
Trypan Blue Ophthalmic Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Trypan Blue 0.03% ophthalmic solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on December 6, 2021.
Product
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0443-2022·2022-02-02
Phenol Topical Solution recalled for CGMP manufacturing deviations
Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0400-2022·2022-02-02
Edge Pharma EDTA Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma, LLC is recalling Edetate Disodium (EDTA) 1.5% Sterile Ophthalmic Solution nationwide due to lack of assurance of sterility. The recalled product is a single-dose eye drop solution.
Product
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0444-2022·2022-02-02
Lidocaine HCl/Phenylephrine HCl Nasal Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution (4%/1%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 231 bottles.
Product
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0448-2022·2022-02-02
Vancomycin HCl Oral Solution Recalled for CGMP Deviations
Edge Pharma is voluntarily recalling 6,925 syringes of Vancomycin HCl Oral Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process.
Product
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, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0393-2022·2022-02-02
Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution
Ascend Laboratories is recalling Metoprolol Succinate Extended-Release Tablets 25 mg nationwide because the tablets failed to meet dissolution specifications, which may affect how the medication releases in the body.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0438-2022·2022-02-02
Lidocaine HCl / Oxymetazoline HCl Nasal Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Lidocaine HCl / Oxymetazoline HCl Nasal Solution (4% / 0.05%, 240mL) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0455-2022·2022-02-02
CTx21 Kit Dental Products Recalled for Subpotent Sodium Fluoride Content
Dental Alliance Holdings LLC is recalling the CTx21 Kit because the product contains less sodium fluoride than stated on the label. Affected lots were distributed nationwide.
Product
CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0446-2022·2022-02-02
Promethazine HCl Topical Ointment Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Promethazine HCl Topical Ointment, 2.5% due to CGMP (Current Good Manufacturing Practice) deviations. The voluntary nationwide recall affects approximately 7,788 syringes distributed across multiple lots.
Product
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0430-2022·2022-02-02
Cantharidin PLUS topical suspension recalled for manufacturing deviations
Edge Pharma, LLC is recalling 2,204 vials of Cantharidin PLUS, a topical gel-forming suspension used to treat skin conditions. The recall is due to manufacturing quality control deviations discovered during production.
Product
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0433-2022·2022-02-02
Drug Recall: Dexamethasone Sodium Phosphate Topical Solution
Edge Pharma, LLC is recalling Dexamethasone sodium phosphate 0.4% topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in 56 cartons.
Product
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2022·2022-02-02
Tetracaine HCl Nasal Solution Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Tetracaine HCl Nasal Solution, 4%, due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 114 bottles distributed nationwide.
Product
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0458-2022·2022-02-02
CariFree CTx4 Gel 5000 Sample Boxes Recalled for Subpotent Fluoride
CariFree sample boxes containing CTx4 Gel 5000 are being recalled because the product contains less Sodium Fluoride than stated on the label. Affected lots are 492106 and 492107, distributed nationwide.
Product
CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0441-2022·2022-02-02
Profound-PE Dental Gel Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 418 jars of the topical oral anesthetic product distributed across multiple lot codes.
Product
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0429-2022·2022-02-02
Drug Recall: Cantharidin Gel-Forming Suspension CGMP Deviations
Edge Pharma, LLC is recalling Cantharidin Gel-Forming Suspension 0.7% nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall involves 1173 vials distributed to healthcare facilities.
Product
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0456-2022·2022-02-02
CariFree CTx26 Kit Recalled for Subpotent Sodium Fluoride Content
Dental Alliance Holdings LLC is recalling the CTx26 Kit because it contains less sodium fluoride than listed on the product label. Affected consumers should contact their dentist or healthcare provider.
Product
CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4f
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0432-2022·2022-02-02
CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.
Product
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0452-2022·2022-02-02
Proctofoam Topical Aerosol Recalled for cGMP Manufacturing Deficiencies
Mylan Pharmaceuticals Inc is voluntarily recalling Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol due to current Good Manufacturing Practice (cGMP) deficiencies. The recall affects 233,199 10-gram aerosol containers distributed nationwide.
Product
PROCTOFOAM — PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0428-2022·2022-02-02
BLT Topical Cream recalled by Edge Pharma for CGMP deviations
Edge Pharma is recalling 1,173 jars of BLT Topical Cream (Benzocaine/Lidocaine/Tetracaine) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, firm-initiated Class II recall.
Product
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0431-2022·2022-02-02
FDA Recalls CSF Otic Insufflation Capsule for CGMP Deviations
Edge Pharma, LLC is recalling 1055 bottles of CSF Otic Insufflation Capsule containing Sulfacetamide Sodium, Ciprofloxacin, and Amphotericin B nationwide due to CGMP manufacturing deviations.
Product
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05
Category
Drug
Distribution
Distributed nationwide

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4551–4575 of 18005