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

4501–4525 of 17964

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-0442-2022·2022-02-02
Profound-PE Dental Gel Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 175 jars of the topical oral anesthetic gel.
Product
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0454-2022·2022-02-02
CTx7 Kit Recalled for Subpotent Sodium Fluoride Content
The FDA is recalling CTx7 Kits distributed nationwide because the product contains less sodium fluoride than stated on the label.
Product
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 by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0451-2022·2022-02-02
Metoprolol Succinate ER Tablets Recall for Failed Dissolution
American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets 50 mg nationwide due to failed dissolution specifications. The affected lots may not release the medication properly, potentially reducing its effectiveness.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0440-2022·2022-02-02
Profound Dental Gel Recalled for CGMP Manufacturing Deviations
Edge Pharma, LLC is recalling 221 jars of Profound Dental Gel (Lidocaine/Prilocaine/Tetracaine 10%/10%/4%) nationwide due to Good Manufacturing Practice (CGMP) deviations identified during production.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
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-0409-2022·2022-02-02
Mitomycin-C Ophthalmic Solution Recall Due to Sterility Assurance
Edge Pharma is recalling Mitomycin-C sterile ophthalmic solution syringes because the manufacturer lacks assurance of sterility. The recall affects 154 syringes distributed nationwide.
Product
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0434-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling 63 vials of Dibutyl Squaric Acid Topical Solution (2%, 10 mL per vial) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0459-2022·2022-02-02
CariFree CTx4 Gel 5000 Subpotent Sodium Fluoride Recall
Dental Alliance Holdings LLC is recalling CariFree CTx4 Gel 5000 fluoride gel tubes because they contain less sodium fluoride than stated on the label. The affected product is CTx12 5000 Kit lot 142017.
Product
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: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
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
ModerateFDA (Drugs)·D-0435-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to CGMP Deviations
Edge Pharma, LLC is recalling 20 vials of Dibutyl Squaric Acid topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The drug was distributed in multiple dose vials containing 1%, 10 mL each.
Product
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0436-2022·2022-02-02
LT Topical Cream Recalled for Manufacturing Practice Deviations
Edge Pharma, LLC is recalling 74 jars of LT Topical Cream (Lidocaine/Tetracaine) nationwide due to deviations from Current Good Manufacturing Practice (CGMP). The firm initiated the voluntary recall on December 6, 2021.
Product
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0445-2022·2022-02-02
Vitamin K Oral Solution Recalled for CGMP Deviations
Edge Pharma is recalling 757 syringes of Vitamin K Oral Solution nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall was initiated voluntarily by the firm and has been terminated.
Product
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0437-2022·2022-02-02
LET Topical Gel drug recall for CGMP deviations
Edge Pharma is recalling 26,917 syringes of LET Topical Gel nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily in December 2021.
Product
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01
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
LowFDA (Drugs)·D-0453-2022·2022-02-02
CariFree CTx4 GEL 5000 Recalled for Subpotent Fluoride Content
CariFree CTx4 GEL 5000 (Lot 142017) contains less sodium fluoride than stated on the label. The product is being recalled and consumers should contact their healthcare provider with questions.
Product
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 Distributed in 12-pk/cases
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0462-2022·2022-01-26
Semglee Insulin Glargine Prefilled Pens Missing Label
Mylan Pharmaceuticals is recalling approximately 73,175 Semglee (insulin glargine) prefilled pens nationwide because some units have a missing label. Patients should check their pens and contact their pharmacist or doctor if affected.
Product
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0377-2022·2022-01-26
SENNA Syrup unit-dose cups recalled for microbial contamination
Lohxa, LLC is recalling SENNA Syrup (sennosides) 8.8 mg/5 mL unit-dose cups due to microbial contamination of the non-sterile product. The recall affects Lot #AM1115S with expiration date 01/2023, distributed nationwide.
Product
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0376-2022·2022-01-26
Clobazam Oral Suspension Recalled for Failed Stability Specifications
VistaPharm is recalling Clobazam Oral Suspension 2.5 mg/mL due to failed stability specifications. The recall affects 18,456 bottles distributed nationwide.
Product
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0389-2022·2022-01-26
Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations
Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.
Product
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0386-2022·2022-01-26
Leader 12HR Allergy & Congestion Relief tablets fail dissolution test
Dr. Reddy's Laboratories is recalling Leader brand 12HR Allergy & Congestion Relief tablets due to failed dissolution specifications. The product may not release its active ingredients properly.
Product
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0390-2022·2022-01-26
Medique Pain-Off Tablets Recalled for Manufacturing Practice Violations
Medique Products is recalling Medique Pain-Off tablets nationwide after an FDA inspection found the products were not manufactured under Current Good Manufacturing Practices.
Product
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0384-2022·2022-01-26
QC Quality Choice Fexofenadine/Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling QC Quality Choice Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg Extended-Release Tablets nationwide due to failed dissolution specifications that may reduce the medication's effectiveness.
Product
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0374-2022·2022-01-26
Clobetasol Propionate Foam Recalled for CGMP Deviations
Ingenus Pharmaceuticals is recalling 45,173 cans of Clobetasol Propionate Foam, 0.05%, nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, FDA Class II recall.
Product
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0385-2022·2022-01-26
CVS Health Allergy Relief D Tablets Recalled for Failed Dissolution
CVS Health Allergy Relief D Extended Release Tablets are being recalled because they failed to meet dissolution specifications. The recall affects 41,784 boxes distributed nationwide.
Product
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Wo
Category
Drug
Distribution
Distributed nationwide

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4501–4525 of 17964