Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.
Astral SteriTech is recalling 59,040 vials of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.
Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across the United States.
YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.
Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.
Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 vials.
Ampicillin for Injection (2g per vial) is being recalled nationwide because the manufacturer cannot assure the product meets sterility standards. All 45,160 affected vials in circulation are included.
The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.
Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.
Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, due to lack of sterility assurance. The nationwide recall affects approximately 112,640 vials.
Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.
Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.
Big Bold Health is recalling Microbiome Rejuvenate dietary supplement bottles due to glass fragment contamination. The recall affects 1,087 bottles distributed nationwide and internationally.
Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.
Apollo Care, LLC recalled 308 bags of fentanyl and ropivacaine injectable solution due to lack of assurance of sterility. The affected product was distributed in Missouri only.
Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.
Boston Scientific's Watchdog Accessory Kit is being recalled because the insertion tool component can become occluded, preventing guidewire passage. The recall affects 10,833 units distributed worldwide.
The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.
Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.
REAL GREEK LLC is recalling Ellenos Vanilla Bean Greek Yogurt 4oz cups due to mislabeling: Lemon Curd yogurt was packaged as Vanilla Bean, and egg is not declared on the label.
Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.
Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.
Boston Scientific recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were distributed worldwide.
Astral SteriTech recalls approximately 393,930 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility, per FDA Class II classification.