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.

12276–12300 of 29164

  • SevereFDA (Drugs)·D-1116-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 100 mg, because FDA testing found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1101-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Health Solutions Pharmacy Center is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1086-2019·2019-04-17

    FDA Recalls Compounded Sodium Chloride Eye Drops Due to Insanitary Conditions

    The FDA is recalling compounded sodium chloride eye drops from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.

    Product
    SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1092-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine Injectable Due to Insanitary Conditions

    FDA is recalling compounded papaverine-phentolamine injectable due to insanitary conditions observed during compounding of sterile drugs.

    Product
    PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1088-2019·2019-04-17

    Professional Compounding Pharmacy Recalls Acetyl-L-Cysteine Eye Drops Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling Acetyl-L-Cysteine 10% eye drops because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1115-2019·2019-04-17

    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) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1105-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Health Solutions Pharmacy Center is recalling compounded papaverine-phenolamine-PGE1 injectable vials because FDA inspectors observed insanitary conditions during the compounding process.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1109-2019·2019-04-17

    FDA Recalls Compounded Papaverine Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling compounded papaverine-phentolamine-PGE1 injectable due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1108-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1090-2019·2019-04-17

    FDA Recalls Compounded Penile Injection Drugs Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling compounded papaverine-phenolamine-PGE1 injections due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1095-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling specific lots of compounded Papaverine-Phentolamine-PGE1 injectable because FDA inspectors observed insanitary conditions during the compounding process.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1083-2019·2019-04-17

    Losartan Potassium Tablets Recalled Due to Nitrosamine Impurity

    Pharma Pac is recalling Losartan Potassium 100 mg tablets because traces of a nitrosamine impurity were found in the active ingredient.

    Product
    Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1248-2019·2019-04-17

    Aurobindo Recalls MARBETA L KIT Vials Due to Particulate Matter

    Aurobindo Pharma USA Inc. is recalling 88,600 vials of MARBETA L KIT because one vial was found to contain a hair.

    Product
    MARBETA L KIT — MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1104-2019·2019-04-17

    FDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1094-2019·2019-04-17

    Professional Compounding Pharmacy Recalls Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling specific lots of Papaverine-Phentolamine-PGE1 Injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1106-2019·2019-04-17

    FDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling a compounded injectable drug because FDA inspectors observed insanitary conditions during its compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V304000·2019-04-17

    Spartan Recalls 2019 Utilimaster Truck Bodies Due to Electrical Fire Risk

    Spartan Motors is recalling 2019 Utilimaster Truck Bodies because undersized wires may overheat, melt, and cause an unexpected engine shutdown, increasing crash risk.

    Product
    UTILIMASTER — UTILIMASTER TRUCK BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V308000·2019-04-17

    Volvo Recalls 2016 XC90 Vehicles for Coolant Hose Fire Risk

    Volvo is recalling 2016 XC90 vehicles because a coolant hose may crack and leak, potentially causing a fire in the catalytic converter area.

    Product
    VOLVO — VOLVO XC90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1102-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling a compounded sterile injectable drug due to insanitary conditions observed during an FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V306000·2019-04-16

    2019 Fleetwood and Holiday Rambler Motorhomes Recalled for Exhaust Defect

    REV is recalling 2019 Fleetwood Flair and Holiday Rambler Admiral motorhomes because the generator exhaust pipe placement may allow carbon monoxide to enter the vehicle.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER FLAIR, ADMIRAL
    Category
    Vehicle
    Distribution
    Distributed nationwide