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.

28176–28200 of 32252

SevereFDA (Drugs)·D-592-2013·2013-06-12
Pentec Health Recalls Proplete 45-51 KG Due to Sterility Concerns
Pentec Health is recalling Proplete 45-51 KG intraperitoneal nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Product
Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-528-2013·2013-06-12
TG United Recalls Lusair Liquid Due to Underdosing and Incorrect Dosage Regime
TG United, Inc. is recalling Lusair Liquid, an over-the-counter product, because it may be underdosed or have an incorrect dosage regime.
Product
Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-559-2013·2013-06-12
Lipoic Acid Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-548-2013·2013-06-12
Methotrexate Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Methotrexate 25mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Food)·F-1474-2013·2013-06-12
LL Bakery Recalls Bread and Danish for Undeclared Milk Allergen
LL Bakery is recalling White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because the labels fail to declare milk as an allergen.
Product
White Farm Enriched White Bread. 16 oz (454g), 9pc/box. UPC 0 10314 10002 0. The label is white with blue and green lettering and red design accents. The LL Bakery Logo is on the bottom left corner.
Category
Food
Distribution
3 states
SevereFDA (Food)·F-1476-2013·2013-06-12
LL Bakery Recalls Bread and Danish for Undeclared Milk Allergen
LL Bakery is recalling specific breads and pastries because the labels fail to declare milk as an allergen.
Product
Italian Cream Danish 8.5 oz (240g), 14pc/box. UPC 0 10314 40056 4. The pastry is braided and has yellow creamy swirls and sliced almonds. The label is white with black lettering and a tan colored border. The LL Bakery Logo is on the bottom left corner.
Category
Food
Distribution
3 states
SevereFDA (Drugs)·D-566-2013·2013-06-12
Compounded Injectable MIC Plus B12 Recalled Due to Sterility Concerns
The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
Product
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Devices)·Z-1467-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
The FDA is recalling 2,716 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-553-2013·2013-06-12
Betamethasone Injectable Recalled for Sterility Assurance Concerns
The Compounding Shop is recalling Betamethasone 6 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-551-2013·2013-06-12
Baclofen Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Baclofen 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
Product
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-518-2013·2013-06-12
TG United Recalls Dallergy Chewable Tablets Due to Underdosing
TG United, Inc. is recalling Dallergy Chewable Tablets because the products are underdosed or have an incorrect dosage regime.
Product
Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-525-2013·2013-06-12
TG United Recalls BroveX PSE DM Due to CGMP Deviations
TG United, Inc. is recalling BroveX PSE DM bottles because they are underdosed or have an incorrect dosage regime.
Product
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-581-2013·2013-06-12
Pentec Health Recalls Proplete 34-39 KG Intradialytic Nutrition Bags
Pentec Health is recalling Proplete 34-39 KG intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Product
Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-505-2013·2013-06-12
TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup
TG United, Inc. is recalling 352 bottles of AMBI 25DPH/7.5PEH Antihistamine, Nasal Decongestant due to CGMP deviations resulting in underdosed products.
Product
AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-590-2013·2013-06-12
Pentec Health Recalls Proplete 80+ KG Due to Sterility Concerns
Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.
Product
Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-594-2013·2013-06-12
Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns
Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Product
Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Devices)·Z-1453-2013·2013-06-12
Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Control Defect
Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
Product
Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-520-2013·2013-06-12
TG United Recalls Cardec Drops Due to Underdosing
TG United, Inc. is recalling Cardec Drops nasal decongestant because the product is underdosed or has an incorrect dosage regime.
Product
Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-542-2013·2013-06-12
TG United Recalls Trigofen DM Drops Due to Underdosing
TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops because the products are underdosed or have an incorrect dosage regime.
Product
Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-568-2013·2013-06-12
Morphine Sulfate Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Morphine Sulfate 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-524-2013·2013-06-12
TG United Recalls BroveX PSE Antihistamine Due to Underdosing
TG United, Inc. is recalling BroveX PSE antihistamine and nasal decongestant tablets because the products are underdosed or have an incorrect dosage regime.
Product
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-587-2013·2013-06-12
Pentec Health Recalls Proplete 52 Intradialytic Nutrition Due to Sterility Concerns
Pentec Health is recalling Proplete 52 intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Product
Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-589-2013·2013-06-12
Pentec Health Recalls Proplete 70+ KG Due to Sterility Concerns
Pentec Health is recalling 38 bags of Proplete 70+ KG renal nutritional solution because sterility could not be assured for the compounded product.
Product
Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-502-2013·2013-06-12
Hospira Recalls Dobutamine in Dextrose Injection Due to Sterility Concerns
Hospira Inc. is recalling 44,748 bags of Dobutamine in Dextrose Injection because a confirmed leak in the primary container raises concerns about sterility.
Product
DOBUTAMINE IN DEXTROSE — DOBUTAMINE IN DEXTROSE (DOBUTAMINE IN DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1466-2013·2013-06-12
Hill-Rom 1000 Hospital Bed Recalled Due to Brake Disengagement Risk
Hill-Rom, Inc. is recalling 8,737 Hill-Rom 1000 Beds because brakes may disengage when the bed frame is subjected to a hard jolt or force.
Product
Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.
Category
Medical Device
Distribution
Distributed nationwide