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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8076–8100 of 8593

  • 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-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-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-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-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-590-2013·2013-06-12

    Pentec Health Recalls Proplete 80+ KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.

    Product
    Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 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-512-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cough Suppressant and Expectorant Bottles

    TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.

    Product
    AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-560-2013·2013-06-12

    Mitomycin Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 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-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-567-2013·2013-06-12

    Testosterone Cypionate Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-546-2013·2013-06-12

    TG United Recalls ZoDen PD Nasal Spray Due to Dosage Errors

    TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.

    Product
    ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
    Category
    Drug
    Distribution
    5 states
  • 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-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-592-2013·2013-06-12

    Pentec Health Recalls Proplete 45-51 KG Due to Sterility Concerns

    Pentec Health is recalling Proplete 45-51 KG intraperitoneal nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.

    Product
    Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
    Category
    Drug
    Distribution
    0 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-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-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-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-564-2013·2013-06-12

    B-Complex Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling B-Complex 100 mg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    B-Complex 100 mg/mL Injectable, 50 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-457-2013·2013-06-05

    Nora Apothecary Recalls PGE-1 Penile Injections Due to Sterility Concerns

    Nora Apothecary is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and the assurance of sterility.

    Product
    PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-491-2013·2013-06-05

    Nora Apothecary Recalls Glutathione Injections Due to Sterility Concerns

    Nora Apothecary is recalling Glutathione 200mg/ml injections nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
    Category
    Drug
    Distribution
    Distributed nationwide