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

7551–7575 of 11856

SevereFDA (Drugs)·D-1317-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 45 units of Morphine Sulfate IV bags due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Product
Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1292-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 units of compounded Hydromorphone HCI syringes due to a lack of assurance of sterility.
Product
Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1329-2016·2016-07-20
Pharmakon Recalls Ketamine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 150 units of compounded Ketamine 2 mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0938-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1191-2016·2016-07-20
Medaus Recalls Hydroxy B12 Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.
Product
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1275-2016·2016-07-20
Pharmakon Recalls Promethazine IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 725 units of compounded Promethazine IV bags due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1210-2016·2016-07-20
Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lipo-Injection vials because the company cannot ensure the product is sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.
Product
LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1273-2016·2016-07-20
Pharmakon Recalls Promethazine Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 40 units of compounded Promethazine injection due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.
Product
Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1264-2016·2016-07-20
Pharmakon Recalls Propofol Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,580 units of compounded Propofol 1% injection because the company cannot ensure the product is sterile.
Product
Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1226-2016·2016-07-20
Medaus Recalls Minoxidil Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling specific lots of Minoxidil 0.5% vials because the company cannot ensure the product is sterile.
Product
MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1225-2016·2016-07-20
Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling M.I.C 25/50/50 vials because the product lacks assurance of sterility. The recall affects 2,000 mL in vials distributed in the U.S., Japan, and New Zealand.
Product
M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1244-2016·2016-07-20
Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific vials of Testosterone Cypionate 25 mg/mL due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.
Product
TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1359-2016·2016-07-20
Hospira Recalls Diazepam Injection Due to Crystallized Active Ingredient
Hospira Inc. is recalling 373,850 tubes of Diazepam Injection USP 10mg/2mL because the product contains particulate identified as crystallized active ingredient.
Product
DIAZEPAM — DIAZEPAM (DIAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1300-2016·2016-07-20
Pharmakon Recalls Midazolam HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 45 bags of compounded Midazolam HCI due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1188-2016·2016-07-20
Medaus Recalls Hyaluronidase Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Hyaluronidase 500U/ML vials because the company cannot assure the sterility of the product. The recall affects lots distributed in the U.S., Japan, and New Zealand.
Product
HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1198-2016·2016-07-20
Medaus Recalls L-Glutathione Vials Due to Sterility Concerns
Medaus, Inc. is recalling L-Glutathione 100mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1280-2016·2016-07-20
Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 18 units of Cefazolin 3GM in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.
Product
Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1183-2016·2016-07-20
Medaus Recalls Estradiolval and Testosterone Vials Due to Sterility Concerns
Medaus, Inc. is recalling Estradiolval and testosterone vials because the company cannot ensure the product is sterile.
Product
ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1185-2016·2016-07-20
Medaus Recalls Folic Acid Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials because the company cannot ensure the product is sterile.
Product
FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1253-2016·2016-07-20
Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Zinc Sulfate 1mg/mL vials because the company cannot ensure the product is sterile.
Product
ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1271-2016·2016-07-20
Pharmakon Recalls Potassium Chloride IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Potassium Chloride IV bags because they may not be sterile. The recall covers products distributed nationwide and to specific VA/DOD facilities.
Product
Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1174-2016·2016-07-20
Medaus Recalls B-Complex Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex with Cyanocobalamin vials because the company cannot ensure the product is sterile.
Product
B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1232-2016·2016-07-20
Medaus Recalls Procaine 2% Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Procaine 2% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1343-2016·2016-07-20
Pharmakon Recalls Bupivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 70 units of Bupivacaine HCI 0.25% bags because the company cannot assure the products are sterile.
Product
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1247-2016·2016-07-20
Medaus Recalls Thiamine Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling specific lots of Thiamine 100 mg/mL vials because the company cannot guarantee the product is sterile.
Product
THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1252-2016·2016-07-20
Medaus Recalls Arginine Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling specific lots of Arginine 100mg/mL vials because the company cannot assure the product is sterile.
Product
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide

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7551–7575 of 11856