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.

12101–12125 of 29164

  • SevereFDA (Drugs)·D-1262-2019·2019-05-08

    Customceutical Compounding Recalls TriMix MEDIUM Injectable Due to Sterility Concerns

    Customceutical Compounding is recalling TriMix MEDIUM injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1248-2019·2019-05-08

    Baxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors

    Baxter Healthcare is recalling 158 SIGMA Spectrum Infusion Pumps because flow rate tests were performed for less than the required time, potentially leading to inaccurate fluid administration.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1249-2019·2019-05-08

    Roche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops

    Roche Diagnostics is recalling 149 cobas e 801 immunoassay analyzers because signal drops after bottle changeovers may lead to incorrect medical decisions.

    Product
    cobas e 801 immunoassay analyzer
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Drugs)·D-1257-2019·2019-05-08

    Customceutical Compounding Recalls Lipoplex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 16 vials of Lipoplex injectable compound because the sterility of the product cannot be assured.

    Product
    Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1249-2019·2019-05-08

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

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

    Product
    Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1254-2019·2019-05-08

    Customceutical Compounding Recalls BPlex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 19 vials of BPlex injectable compound due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1268-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1261-2019·2019-05-08

    Customceutical Compounding Recalls Trimix HIGH Vials Due to Sterility Concerns

    Customceutical Compounding is recalling Trimix HIGH injectable vials because the company cannot ensure the product is sterile. The recall covers 3 vials distributed nationwide.

    Product
    Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1267-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1256-2019·2019-05-08

    Customceutical Compounding Recalls HCG Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 12 vials of compounded HCG injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1253-2019·2019-05-08

    Customceutical Compounding Recalls BPlex Injectable Vials Due to Sterility Concerns

    Customceutical Compounding is recalling 32 vials of BPlex injectable compound because the product lacks assurance of sterility. The recall covers products distributed nationwide.

    Product
    BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1260-2019·2019-05-08

    Customceutical Compounding Recalls Test PROCYP Injectable Due to Sterility Concerns

    Customceutical Compounding is recalling Test PROCYP injectable vials because the company cannot guarantee the product is sterile.

    Product
    Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1269-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1255-2019·2019-05-08

    Customceutical Compounding Recalls Glutathione Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling specific lots of compounded Glutathione 200mg/mL injection vials because the FDA could not ensure the products were sterile.

    Product
    Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1259-2019·2019-05-08

    Customceutical Compounding Recalls Test D Vials Due to Sterility Concerns

    Customceutical Compounding is recalling Test D vials because the manufacturer cannot ensure the injectable solution is sterile.

    Product
    Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1250-2019·2019-05-08

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 25 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1226-2019·2019-05-08

    DePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration

    DePuy Spine is recalling Concorde Lift spinal fusion implants because a complaint trend was observed for post-operative loss of height and migration.

    Product
    Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2019·2019-05-08

    Losartan Potassium/HCTZ Tablets Recalled for Nitrosamine Impurity

    RemedyRepack is recalling Losartan Potassium/HCTZ tablets because FDA testing found a nitrosamine impurity above acceptable levels.

    Product
    Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1263-2019·2019-05-08

    Losartan Potassium Tablets Recalled Due to Trace Nitrosamine Impurity

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets 50 mg due to trace amounts of the impurity NMBA found in the active ingredient.

    Product
    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO…
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1265-2019·2019-05-08

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1308-2019·2019-05-08

    Kingston Pharma Recalls Infant Cough Syrup Due to Microbial Contamination

    Kingston Pharma LLC is recalling DG health NATURALS infant cough syrup due to microbial contamination with Bacillus species. Consumers should stop using the product.

    Product
    DG health NATURALS For Infants 2+ Months+ baby Cough Syrup + Mucus, Natural Grape Flavor, 2 FL OZ (59 mL), UPC: 8 54954 00250 0, Product Code: 003
    Category
    Food
    Distribution
    0 states
  • SevereUSDA FSIS·049-2019·2019-05-04

    Conagra Recalls P.F. Chang's Chicken Entrees for Undeclared Milk Allergen

    Conagra Brands is recalling P.F. Chang's Home Menu Chicken Pad Thai and Chicken Fried Rice products because they contain undeclared milk, a known allergen.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands, Inc. Recalls Chicken Pad Thai and Chicken Fried Rice Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·034-2019 EXP·2019-05-04

    Tyson Recalls Frozen Chicken Strips Due to Metal Contamination

    Tyson Foods is recalling approximately 11.8 million pounds of frozen chicken strips that may contain pieces of metal. The recall follows consumer complaints of foreign matter and oral injuries.

    Product
    Tyson Foods, Inc. — Tyson Foods, Inc. Recalls Chicken Strip Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·19745·2019-05-02

    BRP Recalls 2017 Ski-Doo Snowmobiles Due to Fuel Leak and Fire Hazard

    BRP is recalling approximately 10,000 2017 Ski-Doo MXZ, Summit, and Renegade snowmobiles because a fuel leak can cause a fire. No injuries have been reported.

    Product
    2017 Ski Doo MXZ, Summit and Renegade snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide