The Recall Desk

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.

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351–375 of 673

  • SevereFDA (Drugs)·D-0392-2022·2022-02-02

    Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination

    Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 750 mg tablets due to detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The contamination resulted from manufacturing deviations.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0398-2022·2022-02-02

    Cefuroxime Sterile Ophthalmic Injection Recalled Due to Sterility Concerns

    Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.

    Product
    Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0421-2022·2022-02-02

    Sterile Ophthalmic Solution Lacks Assurance of Sterility

    Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes distributed nationwide.

    Product
    Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2022·2022-02-02

    Phenol Injection Solution Recall Due to Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.

    Product
    Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0425-2022·2022-02-02

    Vancomycin HCl Injection Recall for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.

    Product
    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-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0427-2022·2022-02-02

    Vancomycin HCl IV Injection Recalled Due to Sterility Assurance Concerns

    Edge Pharma is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects approximately 749 bags distributed nationwide.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0416-2022·2022-02-02

    Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall

    Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.

    Product
    Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0408-2022·2022-02-02

    Mitomycin-C Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.

    Product
    Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0424-2022·2022-02-02

    Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance

    Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0419-2022·2022-02-02

    Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall

    Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.

    Product
    Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2022·2022-02-02

    Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance

    Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0426-2022·2022-02-02

    Vancomycin HCl Injection Recalled for Sterility Assurance Issues

    Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.

    Product
    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-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
    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
  • SevereFDA (Drugs)·D-0371-2022·2022-01-19

    Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals is recalling Norepinephrine Bitartrate Injection USP due to lack of assurance of sterility. The affected lot is distributed in Tennessee, Mississippi, and Ohio.

    Product
    Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0369-2022·2022-01-19

    Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure

    Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0375-2022·2022-01-19

    Clobetasol Propionate Ointment Recalled for Microbial Contamination

    Taro Pharmaceuticals is recalling Clobetasol Propionate Ointment USP 0.05% due to the presence of R. Pickettii bacteria in a non-sterile product. The affected lot may have been distributed nationwide through retailers.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2022·2022-01-19

    Methylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension 400 mg/10mL due to lack of assurance of sterility. The recall affects one lot distributed to facilities in Tennessee, Mississippi, and Ohio.

    Product
    MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-0363-2022·2022-01-05

    kleantouch Hand Sanitizer recalled for methanol contamination

    Valisa MFG LLC is recalling kleantouch Hand Sanitizer 8 FL OZ pump bottles nationwide because the product contains methanol and was marketed without FDA approval. Consumers should stop using the product immediately.

    Product
    kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2022·2022-01-05

    dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure

    SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.

    Product
    dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0323-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance

    SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.

    Product
    PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2022·2022-01-05

    dilTIAZem HCl in Dextrose Injection Recalled for Sterility Assurance

    SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.

    Product
    dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0319-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.

    Product
    NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2022·2022-01-05

    SterRx Fentanyl Citrate Injection recalled for lack of sterility assurance

    SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.

    Product
    Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2022·2022-01-05

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 40 bags of Morphine Sulfate in 5% Dextrose Injection (1 mg per mL) distributed nationwide due to lack of assurance of sterility. The product is subject to contamination risk.

    Product
    Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
    Category
    Drug
    Distribution
    Distributed nationwide