The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

18176–18200 of 29217

  • SevereFDA (Drugs)·D-1239-2016·2016-07-20

    Medaus Recalls Taurine Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling Taurine 50 mg/mL vials because the company cannot assure the product is sterile.

    Product
    TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1311-2016·2016-07-20

    Pharmakon Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Norepinephrine Bitartrate 4 mg in 5% Dextrose bags because the company cannot ensure the products are sterile.

    Product
    Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1650-2016·2016-07-20

    Dr. Praeger's Recalls Frozen Black Bean Burgers Due to Listeria Risk

    Dr. Praeger's is voluntarily recalling frozen Chipotle Black Bean Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's Chipotle Black Bean Burger, 4.25 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06621 9, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1347-2016·2016-07-20

    FUCONPO Capsule Recalled for Marketing Without Approved NDA or ANDA

    Murray International Trading Co. is recalling FUCONPO Capsules because they are marketed as dietary supplements but bear drug claims, making them unapproved drugs.

    Product
    FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1306-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 50 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1349-2016·2016-07-20

    FDA Recalls Crocodile Bile Pills Marketed as Unapproved Asthma Drug

    Murray International Trading Co. is recalling Crocodile Bile Pills for Asthma because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1261-2016·2016-07-20

    Pharmakon Recalls Ceftriaxone Injections Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,575 units of compounded Ceftriaxone 1GM injections due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1209-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot guarantee the product is sterile.

    Product
    LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1223-2016·2016-07-20

    Medaus Recalls M.I.C B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C B-Complex vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.

    Product
    M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1317-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 45 units of Morphine Sulfate IV bags due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1285-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Cadd Cassettes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 10mcg/mL cadd cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1186-2106·2016-07-20

    Medaus Recalls GABA 50mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling GABA 50mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1238-2016·2016-07-20

    Medaus Recalls Selenium Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling specific lots of Selenium 200mcg/mL vials because the company cannot ensure the product is sterile.

    Product
    SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1287-2016·2016-07-20

    Pharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling 200 units of compounded Ketamine 50mg/mL syringes due to a lack of assurance of sterility.

    Product
    Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1222-2016·2016-07-20

    Medaus Recalls B-Complex Premix Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of M.I.C B-Complex Premix vials because the company cannot ensure the product is sterile.

    Product
    M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1251-2016·2016-07-20

    Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Zinc Sulfate 10mg/mL vials because the company cannot guarantee the product is sterile.

    Product
    ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1198-2016·2016-07-20

    Medaus Recalls L-Glutathione Vials Due to Sterility Concerns

    Medaus, Inc. is recalling L-Glutathione 100mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1248-2016·2016-07-20

    Medaus Recalls TMG 100 mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling TMG 100 mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2016·2016-07-20

    Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific vials of Hydroxy B12 injection due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.

    Product
    HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1649-2016·2016-07-20

    Dr. Praeger's Recalls Frozen Veggie Burgers for Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 97010 3, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1202-2016·2016-07-20

    Medaus Recalls Lipo #4 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Lipo #4 vials because the FDA cannot assure the product is sterile. The recall affects vials distributed in the U.S., Japan, and New Zealand.

    Product
    LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1233-2016·2016-07-20

    Medaus Recalls Proline 100mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Proline 100mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1284-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Cadd Cassettes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 units of Hydromorphone HCI cadd cassettes because the company cannot guarantee the products are sterile.

    Product
    Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1235-2016·2016-07-20

    Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot assure the sterility of the product.

    Product
    PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01
    Category
    Drug
    Distribution
    Distributed nationwide