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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4476–4500 of 11852

  • SevereFDA (Drugs)·D-0088-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 708 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.

    Product
    PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0099-2020·2019-10-09

    Sermorelin Acetate Vials Recalled for Lack of Sterility Assurance

    KRS Global Biotechnology is recalling Sermorelin Acetate vials due to a lack of assurance of sterility. The recall covers 341 vials distributed nationwide.

    Product
    Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0055-2020·2019-10-09

    KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,625 syringes of Glycopyrrolate (PF) 1 mg/5 mL due to a lack of assurance of sterility.

    Product
    GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321678317
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1883-2019·2019-10-09

    Akorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee sterility.

    Product
    Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0078-2020·2019-10-09

    KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.

    Product
    NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0022-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0058-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.

    Product
    Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0043-2020·2019-10-09

    FDA Recalls Bimix #3 Vials Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling Bimix #3 vials because the company cannot ensure the product is sterile.

    Product
    Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0052-2020·2019-10-09

    KRS Global Fluorescein Vials Recalled for Sterility Assurance Issues

    KRS Global Biotechnology is recalling Fluorescein vials because the company cannot guarantee the product is sterile.

    Product
    Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0017-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-MB12 NAC Injection Syringes for Sterility Concerns

    Colonia Care Pharmacy is recalling 15 syringes of C-MB12 NAC injection solution because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0122-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets 100 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0019-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns

    Colonia Care Pharmacy is recalling 6 vials of C-Papav/Phentol/PGE1 due to a lack of assurance of sterility. The affected product was distributed via patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0059-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0030-2020·2019-10-09

    Colonia Care Pharmacy Recalls Sterility-Compromised C-Papav/Phentol/PGE1 Vials

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0087-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 228 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.

    Product
    PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0068-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl 1% syringes because the company cannot guarantee the product is sterile.

    Product
    LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678424
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2020·2019-10-09

    FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 934 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0095-2020·2019-10-09

    FDA Recalls Sermorelin Vials Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 647 vials of Sermorelin and related peptides because the company cannot ensure the products are sterile.

    Product
    Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0034-2020·2019-10-09

    Colonia Care Pharmacy Recalls Verapamil Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling Verapamil 2.5mg/mL injection vials because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0008-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Cromolyn Sodium Inhalation Solution

    Colonia Care Pharmacy is recalling C-Cromolyn Sodium 20 mg/2 mL inhalation solution due to a lack of assurance of sterility.

    Product
    C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0013-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Hydroxocobalamin Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 15 syringes of C-Hydroxocobalamin 25 mg/mL injection solution because the product's sterility cannot be guaranteed.

    Product
    C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0070-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine and Hyaluronidase Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl and Hyaluronidase syringes due to a lack of assurance of sterility. The recall covers 2,615 syringes distributed nationwide.

    Product
    Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0064-2020·2019-10-09

    FDA Recalls Ketamine Syringes Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 1,044 syringes of Ketamine in 0.9% Sodium Chloride because the product lacks assurance of sterility.

    Product
    Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 649 droptainers of a sterile ophthalmic solution because the company cannot ensure the product's sterility.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine and Epinephrine Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling 4,105 syringes of Lidocaine and Epinephrine due to a lack of assurance of sterility.

    Product
    LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395
    Category
    Drug
    Distribution
    Distributed nationwide