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.

28126–28150 of 32246

SevereFDA (Drugs)·D-593-2013·2013-06-12
Pentec Health Recalls Baxter LL Bag 1% Amino Acids Due to Sterility Concerns
Pentec Health is recalling Baxter LL bag 1% Amino Acids w/KCL because sterility could not be assured for these compounded sterile renal nutritional prescriptions.
Product
Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-522-2013·2013-06-12
TG United Recalls Maxifed DM Due to Underdosing and Incorrect Dosage Regime
TG United, Inc. is recalling Maxifed DM tablets because they are underdosed or have an incorrect dosage regime.
Product
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-510-2013·2013-06-12
TG United Recalls AMBI Cough Syrup Due to Underdosing
TG United, Inc. is recalling 348 bottles of AMBI cough syrup because the product is underdosed or has an incorrect dosage regime.
Product
AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-531-2013·2013-06-12
TG United Recalls Poly-Vent Tablets Due to Incorrect Dosage
TG United, Inc. is recalling Poly-Vent IR and DM tablets because they are underdosed or have an incorrect dosage regime.
Product
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-563-2013·2013-06-12
Compounded Ascorbic Acid Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling compounded Ascorbic Acid 500 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
Product
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-517-2013·2013-06-12
TG United Recalls Dallergy Tablets Due to Underdosing and Dosage Errors
TG United, Inc. is recalling Dallergy tablets because they are underdosed or have an incorrect dosage regime. The recall affects specific lots distributed in five states.
Product
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-569-2013·2013-06-12
Carnosine 5% Eye Drops Recalled for Sterility Concerns
The Compounding Shop is recalling Carnosine 5% Opth drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Devices)·Z-1469-2013·2013-06-12
Recall of Versaport Bladeless Optical Trocar Due to Seal Disengagement
FDA Class II recall of 126,925 Versaport trocars because seals may disengage, risking component entry into the patient's cavity.
Product
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF 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 entry.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-565-2013·2013-06-12
Phosphatidyl Choline Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling Phosphatidyl Choline 10% Injectable due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-562-2013·2013-06-12
FDA Recalls Procaine Injectable Due to Sterility Concerns
The FDA is recalling Procaine 1% Injectable vials due to quality control concerns regarding sterility assurance. The affected products were distributed in four states.
Product
Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-556-2013·2013-06-12
FDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns
The Compounding Shop is recalling Hydroxyprogesterone 250 mg/mL injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.
Product
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Food)·F-1475-2013·2013-06-12
LL Bakery Recalls Bread and Danish for Undeclared Milk Allergen
LL Bakery is recalling specific bread and Danish products because the labels fail to declare milk as an allergen in the whey powder.
Product
Butter Farm Enriched White Bread 16 oz (454g), 9pc/box. UPC 0 10314 10004 4. 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 (Drugs)·D-571-2013·2013-06-12
Compounded MIC Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling MIC Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
Product
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-554-2013·2013-06-12
Dexpanthenol Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Shop is recalling Dexpanthenol 200 mg/mL Injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.
Product
Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Devices)·Z-1457-2013·2013-06-12
Symbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to flow control components that may cause excessively high flow rates.
Product
Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-501-2013·2013-06-12
Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns
Hospira Inc. is recalling 95,700 vials of Diazepam Injection due to a loose crimp on the fliptop vial, which compromises sterility assurance.
Product
DIAZEPAM — DIAZEPAM (DIAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-509-2013·2013-06-12
TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup
TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.
Product
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-552-2013·2013-06-12
Baclofen/Bupivacaine Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Baclofen/Bupivacaine injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
Product
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-508-2013·2013-06-12
TG United Recalls AMBI Antitussive Due to CGMP Deviations
TG United, Inc. is recalling 348 bottles of AMBI 25CPD/200GFN antitussive and expectorant due to CGMP deviations involving incorrect dosage.
Product
AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-584-2013·2013-06-12
Pentec Health Recalls Fresenius Amino Acid Bags Due to Sterility Concerns
Pentec Health is recalling Fresenius 1% Amino Acid bags because sterility could not be assured for compounded renal nutritional prescriptions.
Product
Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-545-2013·2013-06-12
TG United Recalls ZoDen DM Drops Due to Underdosing
TG United, Inc. is recalling ZoDen DM Drops because the product is underdosed or has an incorrect dosage regime.
Product
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-560-2013·2013-06-12
Mitomycin Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
Product
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-529-2013·2013-06-12
TG United Recalls Poly Hist Forte Nasal Decongestant Due to Underdosing
TG United, Inc. is recalling Poly Hist Forte nasal decongestant tablets because they are underdosed or have an incorrect dosage regime.
Product
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
Category
Drug
Distribution
5 states
SevereFDA (Devices)·Z-1470-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C 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 (Devices)·Z-1472-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST 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 entry.
Category
Medical Device
Distribution
Distributed nationwide