Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
Cook Biotech is recalling specific Cook Medical Biodesign Dural Graft devices due to incorrect expiration dates on two units and use of an incorrect Instructions for Use version.
IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty bone graft materials due to a hydration issue that makes the product less cohesive and moldable than intended.
Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.
Akron Pharma is recalling 1,232 bottles of Acetaminophen Extra Strength tablets due to incorrect imprinting on the tablets. The product identification may be wrong on the affected tablets.
Eclectic Herb Vitamin Herb Blend dietary supplement is recalled because the Supplement Facts panel contains incorrect ingredient names and quantities. Consumers should check affected lot numbers.
Akron Pharma recalls 768 bottles of Acetaminophen Extra Strength 500 mg due to incorrect identification imprinted on the tablets nationwide.
Akron Pharma is recalling 14,825 bottles of Acetaminophen 325 mg tablets due to incorrect tablet imprinting affecting lots KDT0124004, KDT0124005, and KDT0124006 (expiring August 31, 2026). No illnesses have been reported.
Sklar Instruments is recalling ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. The kits were distributed nationwide.
Akron Pharma is recalling Diphenhydramine HCl 25 mg capsules nationwide because the capsules are imprinted with incorrect identification. Consumers should stop using the affected product.
DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.
Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.
IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.
Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.
West-Ward Columbus is recalling Methadone Hydrochloride Tablets, 5mg, in unit-dose packaging due to illegible product identification on individual tablets. Lot AC2556A was distributed nationwide.
Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.
Tree House Foods is recalling 2,023 cases of Great Value Chicken Broth due to potential packaging failures that could compromise sterility and cause spoilage. The product was distributed to AL and AR.
AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Solution eye drops due to a label mix-up. The recall affects 16,677 cartons distributed nationwide.
Herr Foods Inc is recalling Wegmans Jalapeno Baked Cheese Puffs due to undeclared monosodium glutamate and flavor compounds. Affected units have expiration dates from December 2024 through May 2025.
AvKARE is recalling Nitrofurantoin 100 mg capsules (NDC 50268-625-15, lot 47101, exp. 02/2026) nationwide because they failed dissolution specifications. Affected users should consult their healthcare provider.
Angiodynamics is recalling 138 units of the Auryon atherectomy laser system due to potential failure to advance to activation mode during use. This malfunction could cause procedural delays or interruptions.
Somerset Therapeutics is recalling Atropine Sulfate Ophthalmic Solution due to failed impurity and degradation specifications. No illnesses have been reported.
AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution eye drops due to a labeling mix-up. The recall affects Lot #0160 and was distributed nationwide.
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% nationwide due to crystallization detected in multiple lots. Patients should contact their pharmacy or healthcare provider for guidance.
Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.
O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.