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.

28351–28375 of 32252

SevereFDA (Drugs)·D-385-2013·2013-05-22
Green Valley Drugs Recalls Manganese Sulfate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Manganese Sulfate Injection because the pharmacy could not ensure the sterility of the compounded products.
Product
Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-403-2013·2013-05-22
Green Valley Drugs Recalls Pyridoxine Hydrochloride Injection for Sterility Concerns
Green Valley Drugs is recalling Pyridoxine Hydrochloride Injection due to lack of assurance of sterility and quality control concerns.
Product
Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-414-2013·2013-05-22
Green Valley Drugs Recalls Thiamine Hydrochloride Injection Due to Sterility Concerns
Green Valley Drugs is recalling Thiamine Hydrochloride Injection because the compounding pharmacy could not ensure the sterility of the products.
Product
Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-354-2013·2013-05-22
Green Valley Drugs Recalls Vitamin D3 Injections Due to Sterility Concerns
Green Valley Drugs is recalling Vitamin D3 injections because the pharmacy could not ensure the products were sterile. The recall covers 18 vials distributed nationwide.
Product
Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-357-2013·2013-05-22
Green Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Dexamethasone Sodium Phosphate Injection because the compounding pharmacy could not ensure the sterility of the products.
Product
Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-402-2013·2013-05-22
FDA Recalls Green Valley Drugs Progesterone Injection for Sterility Concerns
Green Valley Drugs is recalling all Progesterone Injection products due to a lack of assurance of sterility and quality control concerns.
Product
Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-353-2013·2013-05-22
Green Valley Drugs Recalls Buprenorphine Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Buprenorphine Injection due to lack of assurance of sterility and quality control concerns.
Product
Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-370-2013·2013-05-22
Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns
Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-367-2013·2013-05-22
Green Valley Drugs Recalls Furosemide Injection Due to Sterility Concerns
Green Valley Drugs is recalling Furosemide Injection vials because the pharmacy could not ensure the products were sterile. The recall covers 227 vials distributed nationwide.
Product
Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-401-2013·2013-05-22
Green Valley Drugs Recalls Procaine Hydrochloride Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1385-2013·2013-05-22
Heartland Gourmet Gluten Free Cookie Mix Recalled for Undeclared Milk
Heartland Gourmet is recalling specific lots of gluten-free chocolate chip cookie mix labeled as dairy-free because they contain milk.
Product
Heartland Gourmet Gluten Free chocolate chip cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.
Category
Food
Distribution
3 states
SevereFDA (Food)·F-1391-2013·2013-05-22
Eastland Food Recalls Asia Best Salted Mackerel Due to Histamine Levels
Eastland Food Corporation is recalling 210 cases of Asia Best Salted Mackerel because histamine levels indicate product decomposition.
Product
Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 408024***
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-408-2013·2013-05-22
Green Valley Drugs Recalls Sodium Chloride Injection Due to Sterility Concerns
Green Valley Drugs is recalling 318 vials of Sodium Chloride Injection due to a lack of assurance of sterility and quality control concerns.
Product
Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-324-2013·2013-05-22
Gilead Recalls Vistide Injection Due to Particulate Matter
Gilead Sciences is recalling Vistide (cidofovir) injection vials because particulate matter was found in some units. The recall covers 3,181 vials distributed in the US, Canada, and UK.
Product
Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-381-2013·2013-05-22
Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns
Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin Injections nationwide due to a lack of assurance of sterility.
Product
Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-374-2013·2013-05-22
Green Valley Drugs Recalls Hydroxocobalamin Injection Due to Sterility Concerns
Green Valley Drugs is recalling 135 vials of Hydroxocobalamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-375-2013·2013-05-22
Green Valley Drugs Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 229 vials of Hydroxyprogesterone Caproate Injection nationwide due to lack of assurance of sterility.
Product
Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-365-2013·2013-05-22
Green Valley Drugs Recalls Estradiol Valerate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Estradiol Valerate Injection vials because the pharmacy could not ensure the products were sterile. This affects 243 vials distributed nationwide.
Product
Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1342-2013·2013-05-22
Centerville Pie Company Recalls Clam Pies Due to Undeclared Anchovies
Centerville Pie Company is recalling 52 clam pies sold in Massachusetts because they contain undeclared anchovies, a potential allergen risk.
Product
Centerville Pie Company Clam Pie, 2 lb (Large) and 1 lb (Small)
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1408-2013·2013-05-22
Lisy Corp. Recalls Sazonador de Carnes Meat Seasoning for Undeclared Soy
Lisy Corp. is recalling Sazonador de Carnes meat seasoning in 5 oz, 14 oz, and 28 oz sizes due to undeclared soy. The product was distributed in 12 states.
Product
Sazonador de Carnes (Meat Seasoning) in 5 oz, 14 oz, and 28 oz
Category
Food
Distribution
12 states
SevereFDA (Drugs)·D-340-2013·2013-05-22
Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
Green Valley Drugs is recalling Alpha Lipoic Acid Injection vials because the pharmacy could not ensure the products were sterile.
Product
Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-341-2013·2013-05-22
Green Valley Drugs Recalls Amikacin Injection Due to Sterility Concerns
Green Valley Drugs is recalling Amikacin Injection because the pharmacy could not ensure the sterility of the compounded products. The recall covers all strengths and presentations of the drug.
Product
Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-390-2013·2013-05-22
Green Valley Drugs Recalls Methylprednisolone and Bupivacaine Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection due to a lack of assurance of sterility and quality control concerns.
Product
Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-376-2013·2013-05-22
Green Valley Drugs Recalls Ketorolac Injection Due to Sterility Concerns
Green Valley Drugs is recalling 3,289 vials of Ketorolac Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-406-2013·2013-05-22
Green Valley Drugs Recalls Nandrolone and Testosterone Injections for Sterility Concerns
Green Valley Drugs is recalling Nandrolone Decanoate and Testosterone Cypionate injections due to a lack of assurance of sterility and quality control concerns.
Product
Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
Category
Drug
Distribution
Distributed nationwide