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.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate 9 mg Injectable Kits nationwide due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials because they may lack assurance of sterility. The recall covers products prepared between February 22, 2016, and September 14, 2016.
Tri-Coast Pharmacy is recalling Quad Mix injection vials because the FDA cannot assure the products are sterile. The recall covers vials compounded between May and November 2016.
Wells Pharmacy Network LLC is recalling Alprostadil 20 mcg/mL Injectable vials due to a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling 42 vials of Trimix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Country Fresh Products is recalling 6oz containers of Creole Mix sold under Bi-Lo and Winn Dixie brands due to potential Listeria monocytogenes contamination.
Tri-Coast Pharmacy is recalling 105 vials of Amino Acid Recover Eaze because the agency cannot assure the products are sterile.
Royal Seafood Baza, Inc. is recalling Fresh Seafood herring in spicy brine due to potential Listeria monocytogenes contamination. The product was distributed in seven states.
Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
Tri-Coast Pharmacy is recalling 17 vials of TriMix injection because the agency cannot assure the product's sterility. The recall covers products compounded between May and November 2016.
Tri-Coast Pharmacy is recalling 7,168 vials of compounded Testosterone Cypionate in Sesame Oil because the FDA determined there was a lack of assurance of sterility.
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) Injectable Kits because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling 4,884 vials of HCG 5,000 IU due to a lack of assurance of sterility. The products were distributed nationwide.
Tri-Coast Pharmacy is recalling 30 vials of compounded Glucosamine 200 mg/mL because the agency cannot assure the products are sterile.
Royal Seafood Baza, Inc. is recalling refrigerated Pacific Herring Fillets in Oil due to potential Listeria monocytogenes contamination.
Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials due to a lack of assurance of sterility. The recall covers products prepared between February 2016 and September 2016.
Tri-Coast Pharmacy is recalling 25 vials of TriMix injection because the products lack assurance of sterility. The recall covers products compounded between May and November 2016.
Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the agency could not ensure the products were sterile.
Tri-Coast Pharmacy is recalling TriMix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
Hale And Hearty Soups, LLC is recalling 124 bags of 6.9 lb Mulligatawny soup due to potential Listeria monocytogenes contamination. The product was distributed in six states.
Wells Pharmacy Network LLC is recalling 351 vials of Arginine HCl 100 mg/mL Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Tri-Coast Pharmacy is recalling 127 vials of Slim Shot compounded between May and November 2016 due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 882 vials of compounded testosterone products nationwide due to a lack of assurance of sterility.
Tri-Coast Pharmacy is recalling 14 vials of L-Carnitine 250 mg/mL because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.
Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile.