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.

22751–22775 of 32171

  • SevereFDA (Drugs)·D-1130-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

    Akorn, Inc. is recalling Hydroxyzine Hydrochloride oral solution because it failed impurities and degradation specifications. The product was distributed nationwide, including Puerto Rico.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1125-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1127-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-2413-2015·2015-06-17

    FDA Recalls Kr8om Max Kratom Capsules Due to Kratom Content

    Nuevotanicals is recalling Kr8om Max3 and Kr8om Max10 capsules because they contain Kratom. The products were distributed in 12 states.

    Product
    Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 10 capsules; Capsules are packed in a round…
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-1119-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Avastin Syringes Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Avastin syringes because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1738-2015·2015-06-17

    Smith & Nephew R3 Constrained Liner Recalled for Locking Groove Defect

    Smith & Nephew is recalling 40 units of R3 Constrained Liners because the locking groove is oversized, preventing the locking ring from engaging properly.

    Product
    R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2410-2015·2015-06-17

    Nuevotanicals Recalls Kratom Alkaloid Suspension Oil Products

    Nuevotanicals is recalling Kratom alkaloid suspension oil products because they contain Kratom.

    Product
    Kratom (Kr8om) Premium Bali Alkaloid Suspension Oil in 135 mg., 200 mg., and 300 mg. dosages and Kratom (KR8om) Bali Custom Alkaloid Suspension Oil in 175 mg dosage
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-2435-2015·2015-06-17

    AYAA Cheese and Guava Cake Recalled for Undeclared Milk

    AYAA Popcorn Manufacturing Corp. is recalling 180 units of Cheese / Guava Cake 2 oz due to undeclared milk found during an FDA inspection.

    Product
    Cheese / Guava Cake 2 oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1716-2015·2015-06-17

    Fresenius CRIT-LINE Blood Chamber Recalled for Connection Leaks

    Fresenius Medical Care is recalling CRIT-LINE Blood Chambers because the connection may leak during use.

    Product
    CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1770-2015·2015-06-17

    Philips Ingenuity Flex UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 23 Ingenuity Flex UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1779-2015·2015-06-17

    Philips Precedence 6 UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling Precedence 6 UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1126-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials due to lack of assurance of sterility observed during an FDA inspection.

    Product
    Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1128-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Alprostadil injectable vials due to lack of assurance of sterility and objectionable conditions observed during an FDA inspection.

    Product
    Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1699-2015·2015-06-17

    Zimmer Recalls M/L Taper Hip Stems Due to Cytotoxicity Levels

    Zimmer is voluntarily recalling 752 M/L Taper hip implants because they contain higher than allowed cytotoxicity levels, posing a risk of adverse biological response.

    Product
    M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2436-2015·2015-06-17

    AYAA Corn Cake Recalled for Undeclared Milk Allergen

    AYAA Popcorn Manufacturing Corp. is recalling Corn Cake 10 oz and 14 oz packages because FDA inspection found undeclared milk on the labels.

    Product
    Corn Cake 10 oz and 14 oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-2433-2015·2015-06-17

    Sugar Free Vanilla Cake Recalled for Undeclared Milk Allergen

    AYAA Popcorn Manufacturing Corp. is recalling Sugar Free Vanilla Cake 2 oz. because FDA inspection found undeclared milk on the labels.

    Product
    Sugar Free Vanilla Cake 2 oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1122-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Glutathione Nasal Solution Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Glutathione Nasal Solution because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.

    Product
    Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-2429-2015·2015-06-17

    Golden Krust Caribbean Shrimp Patties Recalled for Undeclared Egg

    Golden Krust Caribbean Bakery is recalling Jamaican Style Shrimp Patties due to the presence of undeclared egg.

    Product
    Golden Krust Caribbean JAMAICAN STYLE SHRIMP PATTIES, NET WT. 17.2 LBS, 50 UNBAKED, KEEP FROZEN
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1781-2015·2015-06-17

    Philips Gemini GXL 16 Slice CT Systems Recalled for UPS Battery Hazards

    Philips is recalling 15 Gemini GXL 16 Slice CT systems worldwide because their UPS accessory devices may leak battery acid, overheat, or emit fumes.

    Product
    Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2432-2015·2015-06-17

    AYAA Popcorn Manufacturing Recalls Cheese Cake Due to Undeclared Milk

    AYAA Popcorn Manufacturing Corp. is recalling 10-ounce cheese cakes due to undeclared milk. The product was distributed to local Supermax Supermarket Stores.

    Product
    Bizcocho de Queso (Cheese Cake) 10oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1734-2015·2015-06-17

    Roche Recalls Accu-Chek Spirit Insulin Pumps Due to Mechanical Errors

    Roche Diabetes Care is recalling Accu-Chek Spirit insulin pumps because mechanical errors may stop insulin delivery, potentially leading to severe hyperglycemia.

    Product
    AccuChek Spirit insulin infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1121-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Glutathione Inhalation Solution Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling 20 vials of Glutathione Inhalation solution because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.

    Product
    Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·15V384000·2015-06-17

    Trans Tech Student Safety Transport Recalled for Rear Axle Overload Risk

    Transportation Collaborative, Inc. is recalling 2012-2015 Trans Tech Student Safety Transport buses because the rear axle may fail if loaded to full capacity.

    Product
    TRANS TECH — TRANS TECH STUDENT SAFETY TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1117-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Alprostadil injectable vials because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.

    Product
    Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states