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

4226–4250 of 8589

SevereFDA (Drugs)·D-0265-2017·2017-01-11
Tri-Coast Pharmacy Recalls IV Cocktail #2 Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 132 vials of IV Cocktail #2 nationwide due to a lack of assurance of sterility.
Product
IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by Tri-Co
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0337-2017·2017-01-11
Wells Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Alprostadil 20 mcg/mL Injectable vials due to a lack of assurance of sterility.
Product
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0295-2017·2017-01-11
Tri-Coast Pharmacy Recalls Slim Shot Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 127 vials of Slim Shot compounded between May and November 2016 due to a lack of assurance of sterility.
Product
Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0328-2017·2017-01-11
Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 157 vials of Ultra-Test Injectable nationwide due to a lack of assurance of sterility.
Product
ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0282-2017·2017-01-11
Tri-Coast Pharmacy Recalls Quad Mix Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the agency could not ensure the products were sterile.
Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0344-2017·2017-01-11
Wells Pharmacy Recalls Carnitine-L Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 44 vials of Carnitine-L 250 mg/mL Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0346-2017·2017-01-11
Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits
Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin injectable kits due to a lack of assurance of sterility.
Product
Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0284-2017·2017-01-11
Tri-Coast Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0333-2017·2017-01-11
Wells Pharmacy Recalls NADH Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling NADH injectable compounded in Ocala, FL, due to a lack of assurance of sterility.
Product
Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0270-2017·2017-01-11
Tri-Coast Pharmacy Recalls Lipotropic Injections Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 987 vials of compounded Lipotropic injections nationwide because the agency could not ensure the products were sterile.
Product
Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0309-2017·2017-01-11
Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 17 vials of TriMix injection because the agency could not ensure the products were sterile.
Product
TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0357-2017·2017-01-11
Wells Pharmacy Recalls Injectable Compounded Drug Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 22 vials of a compounded injectable drug due to a lack of assurance of sterility.
Product
Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0306-2017·2017-01-11
Tri-Coast Pharmacy Recalls Testosterone Suspension Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 13 vials of compounded Testosterone Suspension 100 mg/mL due to a lack of assurance of sterility. The recall covers products compounded between May and November 2016.
Product
Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0260-2017·2017-01-11
Tri-Coast Pharmacy Recalls Glutathione Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 367 vials of compounded Glutathione 200 mg/mL nationwide because the products lack assurance of sterility.
Product
Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0256-2017·2017-01-11
Tri-Coast Pharmacy Recalls Dexpanthenol Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Dexpanthenol 250 mg/mL vials because the agency could not ensure the products were sterile.
Product
Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0313-2017·2017-01-11
Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 25 vials of TriMix injection because the products lack assurance of sterility. The recall covers products compounded between May and November 2016.
Product
TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0396-2017·2017-01-11
FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) injectable kits nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0329-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Enanthate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 1,250 vials of compounded Testosterone Enanthate Injectable nationwide due to a lack of assurance of sterility.
Product
Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0296-2017·2017-01-11
Tri-Coast Pharmacy Recalls Taurine Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 90 vials of compounded Taurine 50 mg/mL because the products lack assurance of sterility.
Product
Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0255-2017·2017-01-11
Tri-Coast Pharmacy Recalls Calm Me Compounded Sterile Product Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Calm Me compounded sterile products because there is a lack of assurance of sterility. The recall covers 10 vials distributed nationwide.
Product
Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0336-2017·2017-01-11
FDA Recalls Compounded HCG Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 10 kits of compounded Chorionic Gonadotropin (HCG) injectable kits due to a lack of assurance of sterility.
Product
Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0261-2017·2017-01-11
Tri-Coast Pharmacy Recalls HCG Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 4,884 vials of HCG 5,000 IU due to a lack of assurance of sterility. The products were distributed nationwide.
Product
HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0402-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling compounded Testosterone Cypionate in Sesame Oil Injectable vials due to a lack of assurance of sterility.
Product
Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0398-2017·2017-01-11
Wells Pharmacy Recalls Sodium Bicarbonate Injectable Vials Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 67 vials of Sodium Bicarbonate, 8.4% Injectable, due to a lack of assurance of sterility.
Product
Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0254-2017·2017-01-11
Tri-Coast Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 12 vials of Calcium Gluconate 10% Injection compounded between May and November 2016 due to a lack of assurance of sterility.
Product
Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide

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4226–4250 of 8589