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.

28301–28325 of 32252

SevereFDA (Drugs)·D-363-2013·2013-05-22
Green Valley Drugs Recalls ED Mix Injections Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 10,684 vials of ED Mix Injections nationwide due to a lack of assurance of sterility in compounded products.
Product
ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k)…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-344-2013·2013-05-22
Green Valley Drugs Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
Green Valley Drugs is recalling Bacteriostatic Water for Injection because the company cannot ensure the products are sterile.
Product
Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-371-2013·2013-05-22
Green Valley Drugs Recalls Hyaluronidase Injection Due to Sterility Concerns
Green Valley Drugs is recalling 996 vials of Hyaluronidase Injection because the pharmacy could not ensure the products were sterile.
Product
Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-410-2013·2013-05-22
Green Valley Drugs Recalls Testosterone Injections Due to Sterility Concerns
Green Valley Drugs is recalling 51 vials of Testosterone Cypionate and Testosterone Propionate Injection due to lack of assurance of sterility.
Product
Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-393-2013·2013-05-22
Green Valley Drugs Recalls Methylprednisolone Acetate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Methylprednisolone Acetate Injection products because the company could not ensure the sterility of the compounded and repackaged items.
Product
Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1384-2013·2013-05-22
Heartland Gourmet Gluten-Free Cookie Mix Recalled for Undeclared Milk
Heartland Gourmet is recalling gluten-free double chocolate cookie mix labeled as dairy-free because some products contain milk.
Product
Heartland Gourmet Gluten Free double chocolate cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.
Category
Food
Distribution
3 states
SevereFDA (Drugs)·D-366-2013·2013-05-22
Green Valley Drugs Recalls Folic Acid Injections Due to Sterility Concerns
Green Valley Drugs is recalling 244 vials of Folic Acid Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-359-2013·2013-05-22
Green Valley Drugs Recalls DMPS Injections Due to Sterility Concerns
Green Valley Drugs is recalling 251 vials of DMPS Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Product
Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-349-2013·2013-05-22
FDA Recalls Betamethasone Injection Due to Sterility Assurance Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Betamethasone Combination with Lidocaine and Bupivacaine Injection due to lack of assurance of sterility.
Product
Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-352-2013·2013-05-22
Green Valley Drugs Recalls Bupivacaine Injection Due to Sterility Concerns
Green Valley Drugs is recalling 756 vials of Bupivacaine Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-391-2013·2013-05-22
Green Valley Drugs Recalls Methylprednisolone Injection Due to Sterility Concerns
Green Valley Drugs is recalling 720 syringes of Methylprednisolone, Lidocaine, and Sodium Chloride Injection because the pharmacy could not ensure the products were sterile.
Product
Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-380-2013·2013-05-22
Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 209 vials of Lipotropic With Vitamin Injections nationwide due to a lack of assurance of sterility.
Product
Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-327-2013·2013-05-22
Evol Nutrition Recalls Mojo Nights Capsules for Unapproved Ingredients
Evol Nutrition is recalling Mojo Nights capsules because they contain unapproved ingredients used to treat erectile dysfunction.
Product
Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-400-2013·2013-05-22
Green Valley Drugs Recalls Polidocanol Injection Due to Sterility Concerns
Green Valley Drugs is recalling Polidocanol Injection vials nationwide due to a lack of assurance of sterility and quality control concerns.
Product
Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-387-2013·2013-05-22
Green Valley Drugs Recalls Methylcobalamin Injections Due to Sterility Concerns
Green Valley Drugs is recalling 1,343 vials of Methylcobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.
Product
Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-373-2013·2013-05-22
Green Valley Drugs Recalls Hydrogen Peroxide Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Hydrogen Peroxide Injection due to a lack of assurance of sterility in compounded and repackaged products.
Product
Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1407-2013·2013-05-22
Lisy Corp. Recalls Adobo con Pimienta for Undeclared Soy Allergen
Lisy Corp. is recalling Adobo con pimienta in 5 oz, 14 oz, and 32 oz containers due to an undeclared soy allergen. The product was distributed in 12 states.
Product
Adobo con pimienta (Adobo with pepper) in 5 oz, 14 oz, and 32 oz
Category
Food
Distribution
12 states
SevereFDA (Drugs)·D-346-2013·2013-05-22
Green Valley Drugs Recalls Betamethasone Combination Injection Due to Sterility Concerns
Green Valley Drugs is recalling 295 vials and syringes of Betamethasone Combination Injection because the pharmacy could not ensure the products were sterile.
Product
Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-343-2013·2013-05-22
Green Valley Drugs Recalls Betamethasone Injection Due to Sterility Concerns
Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.
Product
Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-355-2013·2013-05-22
Green Valley Drugs Recalls Cyanocobalamin Injections Due to Sterility Concerns
Green Valley Drugs is recalling 6,292 vials of Cyanocobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.
Product
Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-337-2013·2013-05-22
Mojo nights SUPREME Capsules Recalled for Undeclared Active Ingredients
Performance Plus Marketing, Inc. is recalling Mojo nights SUPREME Capsules because the product was marketed without an approved NDA/ANDA and may contain undeclared sildenafil, tadalafil, and analogues.
Product
Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-417-2013·2013-05-22
NuVision Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns
NuVision Pharmacy is recalling 32 vials of Methylcobalamin Injection due to lack of assurance of sterility and reports of adverse events.
Product
Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-409-2013·2013-05-22
Green Valley Drugs Recalls Sodium Tetradecyl Sulfate Injection for Sterility Concerns
Green Valley Drugs is recalling 203 vials of Sodium Tetradecyl Sulfate Injection due to lack of assurance of sterility and quality control concerns.
Product
Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-405-2013·2013-05-22
Green Valley Drugs Recalls Sodium Bicarbonate and Lidocaine Injection
Green Valley Drugs is recalling 335 vials of Sodium Bicarbonate and Lidocaine Injection due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-360-2013·2013-05-22
Green Valley Drugs Recalls DMSO Injection Due to Sterility Concerns
Green Valley Drugs is recalling Dimethyl Sulfoxide (DMSO) Injection products due to a lack of assurance of sterility and quality control concerns.
Product
Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO 99% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide