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.

22901–22925 of 32171

  • SevereUSDA FSIS·081-2015·2015-05-20

    LQNN Recalls Uninspected Poultry, Beef, and Pork Products

    LQNN, Inc. is recalling 598,374 pounds of poultry, beef, and pork products produced without federal inspection and misbranded with unauthorized USDA marks.

    Product
    California Jerky Factory, Inc. — LQNN, Inc. Recalls Poultry, Beef and Pork Products Produced Without the Benefit of Inspection and Misbranded With Unauthorized Use of the USDA Mark of Inspection
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-2286-2015·2015-05-20

    D&D Foods Summer Fresh Pasta Recalled for Listeria Risk

    D&D Foods, Inc. is recalling Summer Fresh Pasta due to potential Listeria monocytogenes contamination. The product was distributed in Iowa.

    Product
    D&D Foods, Inc. Summer Fresh Pasta 31830, packaged in 8-lb. plastic buckets. The firm name on the label is D&D Foods, Inc., Omaha, NE.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1025-2015·2015-05-20

    Health Innovations Pharmacy Recalls T4/T3 Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling T4 66mcg - T3 10mcg SR Capsules due to inspection findings regarding sterility and stability data.

    Product
    T4 66mcg - T3 10mcg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1060-2015·2015-05-20

    Coconut Oil Suppository Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Coconut Oil Suppositories due to quality control issues affecting sterility and stability.

    Product
    Coconut Oil Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1055-2015·2015-05-20

    Health Innovations Pharmacy Recalls Thymol 2% Solution Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Thymol 2% Solution because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Thymol 2% Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1001-2015·2015-05-20

    Methylcobalamin Injection Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Methylcobalamin 1000 mcg/mL Injection due to quality control issues affecting sterility and stability data.

    Product
    Methylcobalamin 1000 mcg/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1073-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling 8 vials of Papaverine/phentolamine/prostaglandin injection in New York due to lack of assurance of sterility.

    Product
    Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1068-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Prostaglandin Rx Injections Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling 43 vials of Prostaglandin Rx injections in New York due to a lack of assurance of sterility.

    Product
    Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1013-2015·2015-05-20

    Estradiol Vaginal Cream Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Estradiol 0.01% Vaginal Cream due to inspection findings regarding sterility and stability data.

    Product
    Estradiol 0.01% Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1039-2015·2015-05-20

    Nexium Solution Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Nexium 2 mg/1 mL Solution due to quality control issues affecting sterility and stability.

    Product
    Nexium 2 mg/1 mL Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1076-2015·2015-05-20

    Hospira Recalls Magnesium Sulfate Bags Due to Incorrect Barcodes

    Hospira is recalling 181,704 bags of Magnesium Sulfate in Dextrose because some units may have incorrect barcodes that scan as heparin sodium.

    Product
    MAGNESIUM SULFATE IN DEXTROSE — MAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE IN DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2198-2015·2015-05-20

    Peterson's Macadamia Nuts Recalled Due to Salmonella Contamination

    Kanan Enterprises is recalling Peterson's Macadamia Nuts because the product tested positive for Salmonella. The affected nuts were distributed in Ohio and New York.

    Product
    Peterson's Macadamias Net Wt 16 oz. (454g) King Nut Companies Solon, OH 44139 www.petersonsnuts.com INGREDIENTS: Macadamia Nuts, Peanut and/or Canola Oil, Salt. 0 74870 10365 9
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1072-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling 4 vials of Papaverine/phentolamine/prostaglandin injection in New York due to lack of assurance of sterility.

    Product
    Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2256-2015·2015-05-20

    Central Market Teriyaki Salmon Jerky Recalled for Undeclared Soy and Wheat

    World Wide Gourmet Foods is recalling Central Market Teriyaki Salmon Jerky because the packaging mislabels the product as smoked salmon jerky, failing to declare soy and wheat allergens.

    Product
    Central Market Teriyaki Salmon Jerky, 3 oz. per plastic retail pouch. The front label is correctly identified as Teriyaki Salmon Jerky, but the back side was mis-labeled as Smoked Salmon Jerky with the UPC 0 41220 34270 9.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1028-2015·2015-05-20

    FDA Recalls Diclo 3% Cream Due to Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream because inspection observations indicate a lack of assurance of sterility and stability data.

    Product
    Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1003-2015·2015-05-20

    Health Innovations Pharmacy Recalls Laureth-P 1% Injection Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Laureth-P 1% Injection because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1008-2015·2015-05-20

    Health Innovations Pharmacy Recalls EDTA 3% Eye Drops for Sterility Concerns

    Health Innovations Pharmacy is recalling EDTA 3% Eye Drops due to inspection findings regarding sterility and stability data.

    Product
    EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1069-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling specific lots of Papaverine/phentolamine/prostaglandin injection in New York due to a lack of assurance of sterility.

    Product
    Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1063-2015·2015-05-20

    Janssen Recalls Subpotent Ortho-Cept Oral Contraceptive Tablets

    Janssen Pharmaceuticals is recalling Ortho-Cept tablets because they contain less active ingredient than labeled. The recall covers 16,861 cartons distributed in the US and Canada.

    Product
    Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1606-2015·2015-05-20

    GE Healthcare Recalls CARESCAPE Bx50 Monitors for Pacemaker Detection Defect

    GE Healthcare is recalling 110 CARESCAPE Bx50 monitors because they may fail to indicate when pacemaker detection is off, potentially delaying treatment for asystole.

    Product
    GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1004-2015·2015-05-20

    Health Innovations Pharmacy Recalls Trimix Injection Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Trimix #1 (Original) Injection because inspection findings raised concerns about sterility and stability data.

    Product
    Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10 mL), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1016-2015·2015-05-20

    Health Innovations Pharmacy Recalls Ibuprofen 10% Cream Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Ibuprofen 10% cream in North Carolina due to quality control issues affecting sterility and stability data.

    Product
    Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1027-2015·2015-05-20

    Health Innovations Pharmacy Recalls Leucovorin Suspension Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Leucovorin 1 mg/1 mL Suspension due to lack of assurance of sterility and stability data. The recall is limited to North Carolina.

    Product
    Leucovorin 1 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state