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.

19726–19750 of 32115

SevereFDA (Drugs)·D-1262-2016·2016-07-20
Pharmakon Recalls Hydromorphone Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 12 units of Hydromorphone HCl injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Product
Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1316-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 300 bags of Morphine Sulfate 1mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Product
Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41
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 (Food)·F-1635-2016·2016-07-20
Dr. Praeger's Recalls Quinoa Cowboy Veggie Burgers for Listeria Risk
Dr. Praeger's is voluntarily recalling Trader Joe's Quinoa Cowboy Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Product
Trader Joe's Quinoa Cowboy Veggie Burger, 26 x 12 oz. (340g)/box, Best if used by: May-12-2018, UPC 0053 2761, Dist. & Sold Exclusively By: Trader Joe's, Monrovia CA 91016
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1181-2016·2016-07-20
Medaus Recalls DMSO 99.9 Vials Due to Sterility Concerns
Medaus, Inc. is recalling DMSO 99.9 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
DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1299-2016·2016-07-20
Pharmakon Recalls Oxytocin Lactated Ringers Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin in Lactated Ringers due to a lack of assurance of sterility.
Product
Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1333-2016·2016-07-20
Pharmakon Recalls Rocuronium Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 1,925 vials of Rocuronium 10 mg/mL syringes because the company cannot guarantee the product is sterile.
Product
Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70
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 (Food)·F-1630-2016·2016-07-20
Dr. Praeger's Recalls Frozen Veggie Burgers Due to Listeria Risk
Dr. Praeger's is voluntarily recalling Jumbo California Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Product
Dr. Praeger's Purely Sensible Foods Jumbo California Veggie Burger (Vegan), 5.5 oz., 10 lbs (4.54.kg), Best if used by: May 17, 2018, UPC (01) 00080868 01011, Dr. Praegers Sensible Foods, Elmwood Park, NJ 07407
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1242-2016·2016-07-20
Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1304-2016·2016-07-20
Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 670 vials of compounded Hydromorphone HCl 0.4mg/ml due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.
Product
HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1642-2016·2016-07-20
Dr. Praeger's Recalls Frozen Veggie Burgers Due to Listeria Risk
Dr. Praeger's Sensible Foods is voluntarily recalling specific frozen veggie burgers because they may be contaminated with Listeria monocytogenes.
Product
Dr. Praeger's Bombay Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: May-12-2018, UPC (01) 6 0080868 000050 5, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1179-2016·2016-07-20
Medaus Recalls Dexpantenol Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
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-1276-2016·2016-07-20
Pharmakon Recalls Promethazine Compounded Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 485 units of compounded Promethazine 25 mg in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.
Product
Promethazine 25 mg 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 45183-0187-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1230-2016·2016-07-20
Medaus Recalls Nandrolone Decanoate Vials Due to Sterility Concerns
Medaus, Inc. is recalling Nandrolone Decanoate 200mg/mL vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1229-2016·2016-07-20
Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Product
NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1182-2016·2016-07-20
Medaus Recalls EDTA Disodium Vials Due to Sterility Concerns
Medaus, Inc. is recalling EDTA Disodium 15% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1327-2016·2016-07-20
Pharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 800 syringes of Phenylephrine HCI 100mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1279-2016·2016-07-20
Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 100 mL 0.9% Sodium Chloride bags because the company cannot guarantee the products are sterile.
Product
Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1216-2016·2016-07-20
Medaus Recalls Methyl B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling Methyl B12 10mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Product
METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1308-2016·2016-07-20
Pharmakon Recalls Fentanyl and Bupivacaine Compounded Syringes for Sterility Concerns
Pharmakon Pharmaceuticals is recalling 260 syringes of compounded fentanyl and bupivacaine due to a lack of assurance of sterility.
Product
Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1319-2016·2016-07-20
Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 870 bags of compounded Fentanyl and Bupivacaine due to a lack of assurance of sterility.
Product
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48
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-1294-2016·2016-07-20
Pharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling 600 vials of compounded Ketamine 100mg/mL due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.
Product
Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78
Category
Drug
Distribution
Distributed nationwide