Severity 4 of 5
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.
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.
Park Compounding Pharmacy is recalling 2 vials of TRI-MIX 20MCG+0.5MG+15MG/ML due to a lack of assurance of sterility. The recall affects products distributed in California.
JD & SN Inc. is recalling 155 syringes of TRIMIX injectable solution nationwide due to a lack of assurance of sterility.
JD & SN Inc. is recalling specific syringes of Hydroxyprogesterone Caproate Oil because the FDA cannot ensure the sterile compounded drugs are free from contamination.
FDA is recalling 40 syringes of compounded chorionic gonadotropin from Moses Lake Professional Pharmacy due to lack of assurance of sterility.
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.
FDA is recalling Sermorelin/GHRP-6/GHRP-2 injectable solution from Moses Lake Professional Pharmacy due to lack of assurance of sterility.
JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling 30 mL syringes of 100% sterile ethyl alcohol for injection due to a lack of assurance of sterility.
JD & SN Inc. is recalling 11 Hydroxocobalamin syringes because the FDA cannot ensure they are sterile. The recall covers units distributed nationwide.
JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Estradiol 30 mg pellets because the company cannot ensure the products are sterile.
JD & SN Inc. is recalling Procaine MDV Injectable Solution due to a lack of assurance of sterility. The recall covers 30mL and 300mL containers distributed nationwide.
JD & SN Inc. is recalling 18-pellet vials of 76 mg Testosterone Pellets because the FDA determined there is a lack of assurance of sterility.
JD & SN Inc. is recalling methylcobalamin/hydroxocobalamin syringes because the company cannot ensure the products are sterile.
American Pure Whey is recalling Body Construct Meal Replacement, Cinnamon Roll flavor, due to undeclared soy and milk allergens.
JD & SN Inc. is recalling 91 vials of compounded testosterone pellets because the FDA cannot assure the sterility of the product.
FDA is recalling specific lots of compounded testosterone pellets because the manufacturer cannot ensure sterility. Patients should contact their healthcare provider.
JD & SN Inc. is recalling compounded vitamin injectable solutions due to a lack of assurance of sterility.
JD & SN Inc. is recalling 3 syringes of Trimix injectable solution because the FDA could not ensure the drug was sterile.
FDA is recalling compounded injectable glutathione from Moses Lake Professional Pharmacy due to a lack of assurance of sterility.
The FDA is recalling compounded progesterone pellets from Moses Lake Professional Pharmacy because the agency cannot ensure the products are sterile.
JD & SN Inc. is recalling 26 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution nationwide due to a lack of assurance of sterility.
JD & SN Inc. is recalling 51 testosterone pellets nationwide because the FDA determined there is a lack of assurance of sterility.
Moses Lake Professional Pharmacy is recalling estradiol injectable syringes because the company cannot guarantee they are sterile.
The FDA is recalling compounded progesterone pellets from JD & SN Inc. because the manufacturer cannot guarantee the products are sterile.
Moses Lake Professional Pharmacy is recalling compounded folic acid injectable solution because the agency cannot assure the product is sterile.
JD & SN Inc. is recalling DMPS injectable solution because the FDA cannot ensure the product is sterile. Patients should stop using the medication and contact their healthcare provider.