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.

21326–21350 of 32121

SevereFDA (Drugs)·D-0379-2016·2015-11-25
Downing Labs Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 34 vials of Testosterone Cypionate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Product
Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0254-2016·2015-11-25
US Compounding Recalls HCG/B12 Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 7,852 vials of HCG/B12 injection nationwide because deficient practices may have impacted sterility assurance.
Product
HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0241-2016·2015-11-25
US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 6,008 vials of Betamethasone SP PF due to deficient practices that may impact sterility assurance.
Product
Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-313-2016·2015-11-25
Essential Wellness Pharma Recalls LIPO-B Special Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling LIPO-B Special Injection vials because poor sterile production practices created a lack of sterility assurance.
Product
LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0344-2016·2015-11-25
Downing Labs Recalls Riboflavin-5-Phosphate Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Riboflavin-5-Phosphate Injectable vials because the company cannot ensure the product is sterile.
Product
Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0290-2016·2015-11-25
US Compounding Recalls Tropicamide and Phenylephrine Ophthalmic Drops
US Compounding Inc is recalling 751 bottles of Tropicamide 1%/Phenylephrine 2.5% ophthalmic drops due to deficient practices that may impact sterility assurance.
Product
Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0337-2016·2015-11-25
Downing Labs Recalls L-Glutamine Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling L-Glutamine Injectable vials because the company cannot assure the product's sterility. The recall covers all lots distributed in the US and internationally.
Product
L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0221-2016·2015-11-25
Fresco Fresh Strawberry Yogurt Parfait Recalled for Undeclared Almonds
Del Monte is recalling 270 units of Fresco Fresh Strawberry Yogurt Parfait in North Carolina, South Carolina, and Virginia due to potential undeclared almonds.
Product
Fresco Fresh Strawberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub.
Category
Food
Distribution
3 states
SevereFDA (Drugs)·D-0272-2016·2015-11-25
US Compounding Recalls Omnipaque 300 Vials Due to Sterility Concerns
US Compounding Inc is recalling 8,218 vials of Omnipaque 300 injection due to deficient practices that may impact sterility assurance.
Product
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-317-2016·2015-11-25
Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Methylcobalamin 25 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.
Product
Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0289-2016·2015-11-25
US Compounding Recalls Tropicamide and Phenylephrine Eye Drops for Sterility Concerns
US Compounding Inc is recalling 1,833 bottles of Tropicamide 0.5%/Phenylephrine 5% eye drops nationwide due to deficient practices that may impact sterility assurance.
Product
Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0287-2016·2015-11-25
US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns
US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.
Product
Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0248-2016·2015-11-25
US Compounding Recalls Dex LA 8 Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 4,333 vials of Dex LA 8 (Dexamethasone acetate) nationwide because deficient practices may have impacted sterility assurance.
Product
Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0338-2016·2015-11-25
Downing Labs Recalls L-Tyrosine Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling 29 vials of L-Tyrosine Injectable because the product lacks assurance of sterility. The affected product was distributed nationwide and in multiple international markets.
Product
L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0376-2016·2015-11-25
Downing Labs Recalls M.I.C Injection Due to Sterility Concerns
Downing Labs, LLC is recalling M.I.C Injection (Preserved) because the company cannot ensure the product is sterile. The recall affects 172 vials distributed in the US and internationally.
Product
M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0381-2016·2015-11-25
Downing Labs Recalls Magnesium Sulfate Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 304 vials of Magnesium Sulfate Injection because the product lacks assurance of sterility. The affected vials were distributed nationwide and internationally.
Product
Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-335-2016·2015-11-25
Essential Wellness Pharma Recalls TRIMIX #4 Injection Due to Sterility Concerns
Kalman Health & Wellness is recalling TRIMIX #4 Injection vials due to poor sterile production practices that compromise sterility assurance.
Product
TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0265-2016·2015-11-25
US Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns
US Compounding Inc is recalling 3,629 vials of Methylprednisolone 100 mg/mL due to deficient practices that may impact sterility assurance.
Product
MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-301-2016·2015-11-25
Essential Wellness Pharma Recalls BIMIX INJ Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling BIMIX INJ 30 mg-1 mg/mL Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Product
BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-311-2016·2015-11-25
Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns
Kalman Health & Wellness is recalling HCG 10,000 Units/mL injections because poor sterile production practices created a lack of sterility assurance.
Product
HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0368-2016·2015-11-25
Downing Labs Recalls L-Arginine Injection Due to Sterility Concerns
Downing Labs, LLC is recalling L-Arginine Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.
Product
L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0246-2016·2015-11-25
US Compounding Recalls Cyclopent/PE/Tropic Eye Drops Due to Sterility Concerns
US Compounding Inc is recalling 820 bottles of Cyclopent/PE/Tropic eye drops because deficient practices may have compromised sterility assurance.
Product
Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0236-2016·2015-11-25
US Compounding Recalls Acetylcysteine 10% Ophthalmic Solution for Sterility Concerns
US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.
Product
ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-310-2016·2015-11-25
Essential Wellness Recalls HCG Injection Vials Due to Sterility Concerns
Essential Wellness Pharmacy is recalling HCG 5000 Units/mL injection vials because poor production practices raised concerns about the sterility of the compounded drugs.
Product
HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0294-2016·2015-11-25
Fresenius GranuFlo Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to fire.
Product
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide