Severity 4 of 5
Illness, injury, or structural failure has been reported. 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.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Testosterone Half Ultra 125mg/mL due to a lack of assurance of sterility.
Dr. Reddy's is recalling Ranitidine Tablets because an NDMA impurity was detected. Consumers should stop using the product and return it to the pharmacy.
Red Mountain Compounding Pharmacy is recalling S-Amitriptyline 10mg/mL injection vials because the FDA determined there is a lack of assurance of sterility.
Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected in the product.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections because the FDA identified a lack of assurance of sterility.
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.
Red Mountain Compounding Pharmacy is recalling S-Estradiol Valerate 40mg/mL injection vials because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% Injection because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Edetate Disodium 15% Injection because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility.
Dr. Reddy's Laboratories is recalling CVS brand Ranitidine Tablets 75 mg because of the presence of NDMA impurity.
Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the FDA determined there is a lack of assurance of sterility.
Azuma Foods International Inc is recalling specific lots of Frozen Ika Popo (Sugata Yaki) in Hawaii due to potential Listeria monocytogenes contamination.
Medtech SAS is recalling 93 Rosa Brain 3.0 neurosurgical devices because the instrument holder may send tools on incorrect trajectories, potentially leading to improper device placement.
Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall vertically to the end stops of its travel limit.
Red Mountain Compounding Pharmacy is recalling 81 vials of S-Ascorbic Acid 500mg/mL due to a lack of assurance of sterility.
Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Red Mountain Compounding Pharmacy is recalling S-E2/Test Cyp 1mg/4mg sesame oil injections due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling 81 vials of S-HCG 1200U/ML injection solution because the product lacks assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Progesterone/Testosterone 0.05%/0.03% Oil Opth due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in sesame oil due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection Solution vials due to a lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections due to a lack of assurance of sterility.
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.