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.

19676–19700 of 32115

  • SevereFDA (Drugs)·D-1243-2016·2016-07-20

    Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Testosterone Cypionate vials because the company cannot guarantee the product is sterile.

    Product
    TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1268-2016·2016-07-20

    Pharmakon Recalls Adenosine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 12 units of Adenosine 1mg/ml injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1341-2016·2016-07-20

    Pharmakon Recalls Midazolam HCl Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Midazolam HCl 1mg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1225-2016·2016-07-20

    Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C 25/50/50 vials because the product lacks assurance of sterility. The recall affects 2,000 mL in vials distributed in the U.S., Japan, and New Zealand.

    Product
    M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1183-2016·2016-07-20

    Medaus Recalls Estradiolval and Testosterone Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Estradiolval and testosterone vials because the company cannot ensure the product is sterile.

    Product
    ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1282-2016·2016-07-20

    Pharmakon Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 72 bags of Magnesium Sulfate in Lactated Ringers due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2016·2016-07-20

    Murray International Recalls Unapproved Sciatica Pills Marketed as Supplements

    Murray International Trading Co. is recalling 144 bottles of Sciatica Pills because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1232-2016·2016-07-20

    Medaus Recalls Procaine 2% Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Procaine 2% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1280-2016·2016-07-20

    Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 18 units of Cefazolin 3GM in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.

    Product
    Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1168-2016·2016-07-20

    Medaus Recalls B-Complex #3 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex #3 vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.

    Product
    B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1203-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Lipo-Injection vials containing lidocaine and vitamins due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.

    Product
    LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1329-2016·2016-07-20

    Pharmakon Recalls Ketamine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 150 units of compounded Ketamine 2 mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0938-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1643-2016·2016-07-20

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

    Dr. Praeger's Sensible Foods is voluntarily recalling specific frozen veggie burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's Tex Mex Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: Jan -4-2018, UPC (01) 6 0080868 00048 , Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1240-2016·2016-07-20

    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 W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1278-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 4,500 units of Hydromorphone 1mg/mL syringes due to a lack of assurance of sterility.

    Product
    HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1637-2016·2016-07-20

    Dr. Praeger's California Veggie Burgers Recalled for Listeria Risk

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

    Product
    Dr. Praeger's California Veggie Burgers, 12 x 11 oz. (312g)/box, Best if used by: May-16-2018, UPC 0 0080868 000010 7, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1206-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Lipo-Injection vials containing methyl B12 and other vitamins due to a lack of assurance of sterility.

    Product
    LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1266-2016·2016-07-20

    Pharmakon Recalls Epinephrine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 400 syringes of compounded Epinephrine due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.

    Product
    Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1263-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 200 units of Fentanyl Citrate injection due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1286-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 20 syringes of Fentanyl Citrate 25 mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.

    Product
    Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1314-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 75 bags of Fentanyl Citrate injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1260-2016·2016-07-20

    Pharmakon Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 650 syringes of Succinylcholine Chloride 20 mg/mL injection due to a lack of assurance of sterility.

    Product
    Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1190-2016·2016-07-20

    Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.

    Product
    HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1297-2016·2016-07-20

    Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 72 units of compounded Oxytocin 10 Units in Lactated Ringers due to a lack of assurance of sterility.

    Product
    Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1288-2016·2016-07-20

    Pharmakon Recalls Bupivacaine HCI Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 40 units of Bupivacaine HCI 0.125% syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75
    Category
    Drug
    Distribution
    Distributed nationwide