Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

11226–11250 of 11827

SevereFDA (Drugs)·D-583-2013·2013-06-12
Pentec Health Recalls Baxter LL Bag Amino Acids Due to Sterility Concerns
Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Product
Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-567-2013·2013-06-12
Testosterone Cypionate Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
Product
Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-582-2013·2013-06-12
Pentec Health Recalls Baxter Ultrabag Amino Acids Due to Sterility Concerns
Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for compounded sterile renal nutritional prescriptions.
Product
Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. 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-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-514-2013·2013-06-12
Ryddex G Tablets Recalled for Underdosing and Incorrect Dosage Regime
TG United, Inc. is recalling Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.
Product
Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-511-2013·2013-06-12
TG United Recalls Underdosed AMBI Cold and Flu Syrup
TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.
Product
AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-523-2013·2013-06-12
TG United Recalls Maxifed-G Due to Underdosing and Incorrect Dosage
TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.
Product
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
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-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-544-2013·2013-06-12
TG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage
TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.
Product
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
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-521-2013·2013-06-12
TG United Recalls Cardec DM Drops Due to Underdosing
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
Product
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-595-2013·2013-06-12
Pentec Health Recalls Baxter LL Bag 2% Amino Acids Due to Sterility Concerns
Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Product
Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 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 (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 (Drugs)·D-503-2013·2013-06-12
TG United Recalls Underdosed AMBI Cough Syrup Due to CGMP Deviations
TG United, Inc. is recalling 1,398 bottles of AMBI cough syrup in five states because the product is underdosed or has an incorrect dosage regime.
Product
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
Category
Drug
Distribution
5 states
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-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-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-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 (Drugs)·D-564-2013·2013-06-12
B-Complex Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling B-Complex 100 mg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
Product
B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Category
Drug
Distribution
4 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-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-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

How to read this listing

Filters

11226–11250 of 11827