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.
TruVision Health is recalling TruControl 7 Day Trifold dietary supplement (lot WKW72353) because it contains DMHA and hordenine, which the FDA determined are not acceptable dietary supplement ingredients.
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to failed sterility assurance after FDA inspection. 363 bags distributed nationwide.
Country Cookie LLC is recalling Country Cookie Peanut Butter Chocolate Chip cookies sold in Missouri and Kansas retailers because milk is not declared on the label despite being present in the product.
Central Admixture Pharmacy Services is recalling 5,304 bags of phenylephrine injection nationwide after FDA inspection raised concerns about product sterility assurance.
Central Admixture Pharmacy Services recalls Microplegia injectable solution due to FDA concerns about sterility assurance. The product was distributed nationwide across the United States.
Central Admixture Pharmacy Services is recalling 1,300 bags of heparin injection nationwide after an FDA inspection questioned the product's sterility assurance.
Central Admixture Pharmacy Services is recalling 3,055 bags of heparin injection nationwide due to sterility assurance concerns identified during FDA inspection. Healthcare providers and patients should discontinue use of affected lots.
Central Admixture Pharmacy Services is recalling 308 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterility assurance.
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of assured sterility following an FDA inspection. The product poses a potential infection risk to surgical patients.
Central Admixture Pharmacy Services is recalling 544 bags of Cardioplegia Solution distributed nationwide due to lack of sterility assurance identified during FDA inspection. No illnesses have been reported.
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags after FDA inspection questioned whether these injectable products maintain required sterility standards.
Central Admixture Pharmacy Services is recalling 1,735 bags of phenylephrine injectable nationwide after FDA inspection raised concerns about product sterility assurance. No illnesses have been reported.
Great Value Kettle Cooked Lightly Salted Potato Chips from an Ohio distribution center were packaged with incorrect labeling that fails to declare milk protein, posing a risk to consumers with milk allergies.
TruVision Health LLC is recalling Truvy 30-Day Experience Kit because it contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.
Philips recalls the Incisive CT whole-body X-Ray imaging system in 22 units due to potential incorrect image orientation that could result in flipped or reversed images, leading to misdiagnosis, incorrect treatment, or unnecessary radiation exposure.
Central Admixture Pharmacy Services is recalling its Cardioplegia Solution due to lack of assurance of sterility. An FDA inspection determined that the sterility of these products intended for cardiac surgery could not be assured.
Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.
Country Cookie LLC is recalling Oatmeal Raisin Cookies because the label does not declare milk allergen. The recall affects cookies distributed to retailers in Missouri and Kansas.
Central Admixture Pharmacy Services, Inc. is recalling 48 bags of Cardioplegia Solution after an FDA inspection found the manufacturer could not assure the product's sterility. The product was distributed nationwide.
Central Admixture Pharmacy Services is recalling Lidocaine 2% HCl Injectable Solution nationwide due to lack of sterility assurance following an FDA inspection. The recall affects 1,516 bags distributed across the United States.
Country Cookie LLC is recalling Country Cookie Sugar Cookies because the allergen statement does not declare milk, a common allergen. Affected products were distributed to retailers in Missouri and Kansas.
Central Admixture Pharmacy Services is recalling 6,407 bags of phenylephrine injectable solution nationwide because FDA inspection questioned the sterility assurance of the product.
Central Admixture Pharmacy Services is recalling 6,341 bags of NORepinephrine nationwide due to FDA concerns about sterility assurance. An FDA inspection found the manufacturer could not adequately ensure the product's sterility.
TruVision Health LLC is recalling reFORM dietary supplement because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Central Admixture Pharmacy Services is recalling 5,207 bags of heparin injectable nationwide due to an FDA-identified sterility assurance failure. The company cannot guarantee the sterility of affected lot numbers.