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.
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
DYMA Brands is recalling Sysco Low Cal Lemonade (8.6 oz pouches) due to metal fragments introduced during production. The product was distributed across 29 states.
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
Sysco Pink Lemonade 24-ounce pouches are being recalled due to potential metal fragment contamination from a damaged sifter during production. The product was distributed to 29 states.
Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) due to defects in the primary packaging pouch that compromise sterile barrier integrity. The affected dressing was distributed nationwide to IL, TX, and VA.
Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
Armonia Natural Store LLC is recalling OneMultivitaminic GAF-PLUS Advance 300ml for containing undeclared Acetaminophen, Dexamethasone Phosphate, and Aspartame. Consumers should discontinue use immediately.
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Sysco Classic Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. Consumers should not consume the product and should discard it or return it to their retailer.
AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.
Katy's KITCHEN Originals gelatin mix products are being recalled because a damaged sifter introduced metal fragments during manufacturing. The affected flavors are Lemon, Lime, and Orange, distributed across 29 states.
Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.
GE Healthcare Revolution Ascend CT systems can produce progressively rotated images during helical, cine, and cardiac scans. Images after the first may be rotated up to 56 degrees, potentially affecting diagnostic accuracy.
Cedar's Mediterranean Foods is recalling Member's Mark Roasted Red Pepper Hummus due to potential presence of foreign objects. The recall affects 23,136 units distributed to retail locations in ten states.
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.
Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
DYMA Brands recalls THIRSTER Lemonade Drink Mix because a damaged sifter used in dextrose production introduced metal fragments into the product. The product was distributed to 29 states.
Ellington Farms Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. No illnesses have been reported. The product was distributed to 29 states.
DYMA Brands is recalling Culinary Secrest Originals Vanilla Instant Pudding Mix because a damaged sifter introduced metal fragments into the product. Consumers should not consume the product.
VENOFER (iron sucrose) injection is being recalled nationwide because certain vials may contain glass particles from potential glass delamination. Patients and healthcare providers should contact their pharmacist or healthcare provider immediately.
Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.