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.
Volkswagen Group of America is recalling 2,584 2022 Audi A3 and S3 sedans because the seat belt tensioners may not restrain occupants properly during a crash.
Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.
Tailor Made Compounding is recalling 1,562 vials of Sermorelin/Glycine injectable distributed nationwide because the manufacturer cannot assure the product meets sterility standards. Patients should stop using the recalled product and contact their healthcare provider.
Market Day Krabbycakes (840 bags, Item 3320) are being recalled because they contain undeclared shrimp and carmine colorant. The product was distributed across multiple states; consumers with shellfish allergies should not consume it.
Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.
Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.
Sun Pharmaceutical recalls 50,860 vials of Testosterone Cypionate Injection due to water leakage during manufacturing that could affect product sterility. The firm-initiated recall was reported in July 2022 and affects nationwide distribution.
Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.
TMC Acquisition LLC is recalling Folic Acid 5mg/mL injectable vials due to lack of assurance of sterility. The recall affects 45 units distributed nationwide and in Puerto Rico.
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
TMC Acquisition LLC is recalling Alpha Lipoic Acid 25mg/mL vials due to lack of assurance of sterility in manufacturing. The product was distributed nationwide.
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
TMC Acquisition LLC is recalling testosterone injectable products (58 vials) distributed nationwide and to Puerto Rico due to lack of assurance of sterility in manufacturing.
Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in Puerto Rico.
Ready Dough Pizza Inc. is recalling approximately 8,018 pounds of pizza products produced without federal inspection and containing undeclared allergens.
Isuzu is recalling 2022 FTR and FVR trucks because a software error disables engine braking, potentially increasing stopping distances and crash risk.
Westfield Outdoor is recalling approximately 5,050 Cabela's Outfitter and Big Horn camping tents because the stove jack ring can deteriorate under heat and create smoke inside the tent, posing a smoke inhalation risk.
Chrysler is recalling Mopar Tire Air Pressure Sensors because the battery may fail prematurely. This can cause the system to stop working, increasing the risk of a crash.
Blue Bird is recalling 2018-2022 school buses with Cummins electric drivetrains because an improperly grounded air compressor poses an electric shock risk.
Blue Bird is recalling one 2022 All American transit bus because an improperly grounded air compressor can cause electric shock.
Sakar International is recalling about 12,655 Tony Hawk Silver Metallic multi-purpose helmets sold at Walmart from March to June 2022. The helmets do not meet federal safety standards for positional stability and retention, and may fail to protect in a crash.
Siemens Dimension CTNI cardiac troponin test is recalled for positive bias (falsely elevated readings) in Lithium Heparin plasma samples, which may lead to misdiagnosis of myocardial infarction.
Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.
Fresenius Medical Care recalled NaturaLyte 2301 dialysate in Texas and Louisiana after exposure to below-recommended storage temperatures. The exposure may cause packaging leaks, potentially leading to biological contamination and bloodstream infection risk.
EAT REAL FOOD LLC is recalling Culina Plant Based Yogurt nationwide due to potential glass fragments in the product. Affected units were distributed to all states.