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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7226–7250 of 17772

  • SevereFDA (Drugs)·D-0031-2020·2019-10-09

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

    Colonia Care Pharmacy is recalling C-Phenol/Cottonseed Oil Injection 5% vials because the sterility of the product cannot be guaranteed.

    Product
    C-PHENOL/COTTONSEED OIL INJ 5%, 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-0071-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine/Bupivacaine/Hyaluronidase ophthalmic injections due to a lack of assurance of sterility.

    Product
    LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 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 3321678362
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0051-2020·2019-10-09

    FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,882 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 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 33216286000
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0027-2020·2019-10-09

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

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

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/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-0094-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Injections Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin Acetate injections because the company cannot ensure the product is sterile. The recall covers 218 cartridges distributed nationwide.

    Product
    Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0086-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 15,260 syringes of Phenylephrine HCl injection nationwide due to a lack of assurance of sterility.

    Product
    PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2020·2019-10-09

    FDA Recalls Hyaluronidase Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling 928 vials of Hyaluronidase Ophthalmic Injection because the product lacks assurance of sterility.

    Product
    Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0018-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Methylcobalamin Injections Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 191 syringes of C-Methylcobalamin 25mg/mL injection because the product's sterility cannot be guaranteed.

    Product
    C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0007-2020·2019-10-09

    Colonia Care Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of Calcium Gluconate 1% Injection because the sterility of the product cannot be guaranteed.

    Product
    C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0056-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 6,620 vials of Human Chorionic Gonadotropin 11,000 Units due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2020·2019-10-09

    KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0062-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.

    Product
    Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0015-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Interferon Alfa2B Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Interferon Alfa2B ophthalmic solution because the product's sterility cannot be guaranteed.

    Product
    C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0063-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 30 mg/30 mL for IM use due to a lack of assurance of sterility.

    Product
    Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 6,747 vials of Vitamin 10 B Lyophilized for IM use nationwide due to a lack of assurance of sterility.

    Product
    Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0003-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific lots of C-Acetylcysteine Ophthalmic 10% Solution because the sterility of the product cannot be guaranteed.

    Product
    C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0100-2020·2019-10-09

    Sermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns

    KRS Global Biotechnology is recalling 120 vials of Sermorelin and GHRP-2 because the company cannot assure the products are sterile.

    Product
    Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2020·2019-10-09

    Alkermes Recalls Vivitrol Kits Due to Needle Labeling Error

    Alkermes is recalling 16,231 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not affected.

    Product
    VIVITROL — VIVITROL (NALTREXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0066-2020·2019-10-09

    Labetalol HCl syringes are recalled due to lack of sterility assurance

    The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.

    Product
    Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0125-2020·2019-10-02

    FDA Recalls Quinacrine Dihydrochloride Bulk API Due to Labeling Error

    Darmerica, LLC is recalling 1.8 kilograms of bulk Quinacrine Dihydrochloride API because testing revealed the product was actually Artemisinin.

    Product
    Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0036-2020·2019-10-02

    Natpara Injection Cartridges Recalled for Potential Needle Clogging

    Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0038-2020·2019-10-02

    Natpara Injection Recall Issued for Potential Needle Clogging and Underdosing

    Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0037-2020·2019-10-02

    Natpara Injection Cartridges Recalled for Potential Needle Clogging

    Shire is recalling Natpara (parathyroid hormone) injection cartridges because rubber stopper particles may clog the needle, leading to underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0035-2020·2019-10-02

    Natpara Injection Recall Due to Potential Needle Clogging and Underdosing

    Shire is recalling Natpara (parathyroid hormone) injections because rubber stopper particles may clog the needle, potentially causing underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1881-2019·2019-10-02

    Johnson Matthey Recalls Cisplatin Active Pharmaceutical Ingredient Due to Glass Contamination

    Johnson Matthey Inc. is recalling 26,625 grams of Cisplatin Active Pharmaceutical Ingredient due to potential glass contamination.

    Product
    Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
    Category
    Drug
    Distribution
    Distributed nationwide