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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8051–8075 of 8593

  • SevereFDA (Drugs)·D-541-2013·2013-06-12

    TG United Recalls Trigofen Drops Due to Underdosing and Dosage Errors

    TG United, Inc. is recalling specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-536-2013·2013-06-12

    Mesehist WC Recalled for Underdosing and Incorrect Dosage Regime

    TG United, Inc. is recalling Mesehist WC cough and cold medicine due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.

    Product
    Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-584-2013·2013-06-12

    Pentec Health Recalls Fresenius Amino Acid Bags Due to Sterility Concerns

    Pentec Health is recalling Fresenius 1% Amino Acid bags because sterility could not be assured for compounded renal nutritional prescriptions.

    Product
    Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-583-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-594-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-586-2013·2013-06-12

    Pentec Health Recalls Proplete 40 Intradialytic Parenteral Nutrition Bags

    Pentec Health is recalling 9 bags of Proplete 40 intradialytic parenteral nutrition due to a lack of assurance of sterility.

    Product
    Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-524-2013·2013-06-12

    TG United Recalls BroveX PSE Antihistamine Due to Underdosing

    TG United, Inc. is recalling BroveX PSE antihistamine and nasal decongestant tablets because the products are underdosed or have an incorrect dosage regime.

    Product
    BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-558-2013·2013-06-12

    FDA Recalls Glutathione Injectable Due to Sterility Concerns

    The Compounding Shop is recalling Glutathione 200 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-517-2013·2013-06-12

    TG United Recalls Dallergy Tablets Due to Underdosing and Dosage Errors

    TG United, Inc. is recalling Dallergy tablets because they are underdosed or have an incorrect dosage regime. The recall affects specific lots distributed in five states.

    Product
    Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-569-2013·2013-06-12

    Carnosine 5% Eye Drops Recalled for Sterility Concerns

    The Compounding Shop is recalling Carnosine 5% Opth drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-509-2013·2013-06-12

    TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup

    TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-555-2013·2013-06-12

    Dexamethasone Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling Dexamethasone 10 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-511-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cold and Flu Syrup

    TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-502-2013·2013-06-12

    Hospira Recalls Dobutamine in Dextrose Injection Due to Sterility Concerns

    Hospira Inc. is recalling 44,748 bags of Dobutamine in Dextrose Injection because a confirmed leak in the primary container raises concerns about sterility.

    Product
    DOBUTAMINE IN DEXTROSE — DOBUTAMINE IN DEXTROSE (DOBUTAMINE IN DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-593-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 1% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 1% Amino Acids w/KCL because sterility could not be assured for these compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-566-2013·2013-06-12

    Compounded Injectable MIC Plus B12 Recalled Due to Sterility Concerns

    The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-552-2013·2013-06-12

    Baclofen/Bupivacaine Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Baclofen/Bupivacaine injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-501-2013·2013-06-12

    Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns

    Hospira Inc. is recalling 95,700 vials of Diazepam Injection due to a loose crimp on the fliptop vial, which compromises sterility assurance.

    Product
    DIAZEPAM — DIAZEPAM (DIAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-554-2013·2013-06-12

    Dexpanthenol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Dexpanthenol 200 mg/mL Injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-595-2013·2013-06-12

    Pentec Health Recalls Baxter LL Bag 2% Amino Acids Due to Sterility Concerns

    Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-523-2013·2013-06-12

    TG United Recalls Maxifed-G Due to Underdosing and Incorrect Dosage

    TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.

    Product
    Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-565-2013·2013-06-12

    Phosphatidyl Choline Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling Phosphatidyl Choline 10% Injectable due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-521-2013·2013-06-12

    TG United Recalls Cardec DM Drops Due to Underdosing

    TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-568-2013·2013-06-12

    Morphine Sulfate Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Morphine Sulfate 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-556-2013·2013-06-12

    FDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns

    The Compounding Shop is recalling Hydroxyprogesterone 250 mg/mL injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states