The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

9751–9775 of 29157

  • SevereFDA (Devices)·Z-1678-2020·2020-04-15

    Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems

    Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.

    Product
    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1679-2020·2020-04-15

    Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose

    Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.

    Product
    ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1081-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

    PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because the company could not ensure the products were sterile.

    Product
    ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1100-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets because an impurity was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1082-2020·2020-04-15

    PharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns

    PharMEDium Services LLC is recalling 46 lots of nICARdipine HCl injection products because of a lack of sterility assurance.

    Product
    nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1629-2020·2020-04-15

    Zeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass

    Zeiss is recalling a component for LSM 700, 800, and 900 microscopes because tilting the light arm can bypass laser safety, causing Class IIIB laser radiation emission.

    Product
    Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1091-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1121-2020·2020-04-15

    Dragon Pain Balm Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Dragon Pain Balm because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0888-2020·2020-04-15

    Amy's Kitchen Recalls Frozen Vegetable Lasagna Due to Metal Contamination Risk

    Amy's Kitchen is recalling specific lots of frozen gluten-free vegetable lasagna sold in the UK due to potential metal contamination.

    Product
    Amy's Kitchen gluten Free Vegetable Lasagna, UK Microwave or oven bake - keep frozen Item # 000374, UPC 0 042272 003747 net weight 255g Amy's Kitchen Bedford MK
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1140-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lipidtrol Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Lipidtrol 500mg capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Lipidtrol, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1083-2020·2020-04-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1087-2020·2020-04-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1133-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes Off Due to Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Herpes Off because the product is misbranded as an unapproved new drug. The product was sold online in the U.S. and internationally.

    Product
    Herpes Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1085-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate infusions because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1089-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Lots for Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products due to a lack of sterility assurance.

    Product
    fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2020·2020-04-15

    Herbal Doctor Remedies Recalls Thyro-H Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Thyro-H 500mg capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Thyro-H, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1090-2020·2020-04-15

    PharMEDium Recalls 46 Lots of IV Products Due to Sterility Concerns

    PharMEDium Services, LLC is recalling 46 lots of various IV products because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1102-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to NMBA Impurity

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 100 mg because an impurity called NMBA was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1099-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Alprostadil, Papaverine, and Phentolamine injection due to a lack of assurance of sterility. The product was distributed to patients in California, Maine, and Texas.

    Product
    Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1093-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.

    Product
    fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1103-2020·2020-04-15

    Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Avet Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., E
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1097-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Hydroxyprogesterone Caproate Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Hydroxyprogesterone Caproate injections because the FDA cannot ensure the product is sterile. Patients in California, Maine, and Texas should stop using the medication.

    Product
    Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1680-2020·2020-04-15

    Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk

    Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.

    Product
    PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states