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 the agency’s own highest classification or reported deaths or serious injuries, 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

11051–11075 of 17785

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-0314-2017·2017-01-11
Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling TriMix injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
Product
TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0290-2017·2017-01-11
Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Sermorelin Forte 6 mg vials because the agency could not ensure the products were sterile.
Product
Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0341-2017·2017-01-11
FDA Recalls Compounded Injectable Due to Lack of Sterility Assurance
Wells Pharmacy Network is recalling Arginine/Citrulline/Ornit+Lido injectable vials due to a lack of assurance of sterility.
Product
Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0277-2017·2017-01-11
Tri-Coast Pharmacy Recalls Mineral Mix Schrader Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 36 vials of Mineral Mix Schrader because the agency cannot assure the products are sterile. The recall covers products compounded between May and November 2016.
Product
Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0293-2017·2017-01-11
Tri-Coast Pharmacy Recalls Sermorelin Forte Plus Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 2,116 vials of Sermorelin Forte Plus 27 mg because the products lack assurance of sterility.
Product
Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0323-2017·2017-01-11
Tri-Coast Pharmacy Recalls Ultra Cocktail #2 Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 123 vials of Ultra Cocktail #2 compounded between May and November 2016 because the agency cannot assure the products are sterile.
Product
Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0365-2017·2017-01-11
Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Methylcobalamin 1,000 mcg/mL Injectable vials because the agency could not ensure the product was sterile.
Product
Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0415-2017·2017-01-11
Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile. The recall covers vials prepared between February 2016 and September 2016.
Product
Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0251-2017·2017-01-11
Tri-Coast Pharmacy Recalls BiMix Phentolamine/Papaverine Due to Sterility Concerns
Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine vials because the agency cannot assure the products are sterile.
Product
BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0327-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.
Product
Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0248-2017·2017-01-11
Tri-Coast Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 201 vials of compounded Ascorbic Acid 500 mg/mL due to a lack of assurance of sterility.
Product
Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0380-2017·2017-01-11
Wells Pharmacy Recalls Mitomycin Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 2,336 Mitomycin 40 mg Injectable kits nationwide due to a lack of assurance of sterility.
Product
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
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-0322-2017·2017-01-11
Tri-Coast Pharmacy Recalls Ultra Amino Energy Cocktail Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 870 vials of Ultra Amino Energy Cocktail nationwide due to a lack of assurance of sterility.
Product
Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0406-2017·2017-01-11
Wells Pharmacy Recalls TitanMax Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 18 vials of TitanMax-MIC/12/CA/CH/L/D Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Product
TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0362-2017·2017-01-11
Wells Pharmacy Recalls Indocyanine Green Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 131 kits of Indocyanine Green (P.F.) 15 mg Injectable due to a lack of assurance of sterility.
Product
Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
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-0343-2017·2017-01-11
Wells Pharmacy Recalls Bimix Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Bimix 30 mg/1 mg/mL Injectable vials because the product lacks assurance of sterility.
Product
Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
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-0384-2017·2017-01-11
Wells Pharmacy Recalls QUAD2 Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling QUAD2 injectable vials because they may not be sterile. The recall covers vials prepared between February and September 2016.
Product
QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0358-2017·2017-01-11
Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 147 vials of a compounded injectable drug due to a lack of assurance of sterility. The products were distributed nationwide.
Product
Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0392-2017·2017-01-11
FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0298-2017·2017-01-11
Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 400 vials of compounded Testosterone Cypionate in Sesame because the products lack assurance of sterility.
Product
Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0334-2017·2017-01-11
Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 714 vials of Ultra-Test in Grapeseed Oil Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Product
ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide

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11051–11075 of 17785