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.
Pharm D Solutions is recalling Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable due to lack of assurance of sterility. The product was distributed nationwide.
Aurobindo Pharma is recalling Irbesartan bulk active ingredient because N-Nitrosodimethylamine (NDEA), a carcinogen, was detected. The product was distributed to one customer in New York.
P. East Trading Corp. is recalling Fruits Du Sud Golden Seedless Raisins because the product contains undeclared sulfites.
Pharm D Solutions is recalling Phenol 5% and Glycerin Aqueous Solution 10 mL Injection due to a lack of assurance of sterility.
Pharm D Solutions is recalling Trimix T 101 Injectable due to a lack of assurance of sterility. The recall covers a specific lot distributed nationwide.
Pharm D Solutions is recalling 25 bottles of Calcium Gluconate 1% Eyewash Ophthalmic Solution because the company cannot ensure the product is sterile.
Pharm 184 vials of Zinc Sulfate 1 mg/mL MDV Injectable are being recalled nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Lipo MIC-12 Compound Injectable vials nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Trimix QM10 Injectable because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 114 vials of HCG 50,000 unit lyophilized powder nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Prostaglandin E1 80 mcg/mL Injectable nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Phosphate Buffer Solution 0.05 m Aqueous Solution because the company cannot assure the product's sterility.
Pharm D Solutions is recalling 442 vials of HCG 6000 unit injectable nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 1,171 vials of HCG 10,000 unit/0.3 gm Mannitol Lyopholized nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling Slenderella Compound Injectable because the product lacks assurance of sterility.
Stryker GmbH is recalling 867 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the medical device.
Stryker GmbH is recalling 1,355 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising frame stability.
Pharm D Solutions is recalling specific lots of Trimix Injectable because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling Acetylcysteine Injection 10 mg/5 mL because the agency could not ensure the product was sterile.
Siemens is recalling 31 Ysio MAX radiographic systems because steel cables in the lifting column may rupture, causing the arm to drop unexpectedly.
Avella of Deer Valley is recalling 300 bags of Phenylephrine 25 mg in NS 250 mL due to a lack of assurance of sterility.
Pharm D Solutions is recalling 264 vials of Oxytocin 30 unit in LR 500 mL IV bags nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Trimix Injectable because the company cannot guarantee the product is sterile.
Maquet Datascope is recalling Cardiosave Hybrid IABP devices due to a potential inability to start therapy for users at altitudes above 3,200 feet.