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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11276–11300 of 11827

  • SevereFDA (Drugs)·D-544-2013·2013-06-12

    TG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage

    TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.

    Product
    Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-559-2013·2013-06-12

    Lipoic Acid Injectable Recalled for Sterility Concerns

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

    Product
    Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-530-2013·2013-06-12

    TG United Recalls Poly-Vent DM Tablets Due to Dosage Deviations

    TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.

    Product
    Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-545-2013·2013-06-12

    TG United Recalls ZoDen DM Drops Due to Underdosing

    TG United, Inc. is recalling ZoDen DM Drops because the product is underdosed or has an incorrect dosage regime.

    Product
    ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-537-2013·2013-06-12

    TG United Recalls TL-DEX DM Cough Suppressant Due to Dosage Errors

    TG United, Inc. is recalling 2,532 bottles of TL-DEX DM cough suppressant because the product is underdosed or has an incorrect dosage regime.

    Product
    TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-531-2013·2013-06-12

    TG United Recalls Poly-Vent Tablets Due to Incorrect Dosage

    TG United, Inc. is recalling Poly-Vent IR and DM tablets because they are underdosed or have an incorrect dosage regime.

    Product
    Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-553-2013·2013-06-12

    Betamethasone Injectable Recalled for Sterility Assurance Concerns

    The Compounding Shop is recalling Betamethasone 6 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-549-2013·2013-06-12

    Avastin Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-561-2013·2013-06-12

    Methylcobalamin Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Methylcobalamin 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-572-2013·2013-06-12

    Tri-Mix Injections Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Tri-Mix Injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • 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-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-581-2013·2013-06-12

    Pentec Health Recalls Proplete 34-39 KG Intradialytic Nutrition Bags

    Pentec Health is recalling Proplete 34-39 KG intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-522-2013·2013-06-12

    TG United Recalls Maxifed DM Due to Underdosing and Incorrect Dosage Regime

    TG United, Inc. is recalling Maxifed DM tablets because they are underdosed or have an incorrect dosage regime.

    Product
    Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-520-2013·2013-06-12

    TG United Recalls Cardec Drops Due to Underdosing

    TG United, Inc. is recalling Cardec Drops nasal decongestant because the product is underdosed or has an incorrect dosage regime.

    Product
    Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-562-2013·2013-06-12

    FDA Recalls Procaine Injectable Due to Sterility Concerns

    The FDA is recalling Procaine 1% Injectable vials due to quality control concerns regarding sterility assurance. The affected products were distributed in four states.

    Product
    Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-591-2013·2013-06-12

    Pentec Health Recalls Proplete 90+ KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 90+ KG dialysate solution because sterility could not be assured. The product was distributed to dialysis centers and directly to patients.

    Product
    Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-534-2013·2013-06-12

    TG United Recalls CPM PSE DM Drops Due to Underdosing

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

    Product
    CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-519-2013·2013-06-12

    TG United Recalls Brompheniramine/Pseudoephedrine DM Liquid Due to Underdosing

    TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.

    Product
    BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
    Category
    Drug
    Distribution
    5 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-542-2013·2013-06-12

    TG United Recalls Trigofen DM Drops Due to Underdosing

    TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
    Category
    Drug
    Distribution
    5 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-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-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