Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
LivaNova USA is recalling 140 sterile disposable connectors because some packages contained incorrect 3/8x1/4 reducers instead of the specified 1/2x1/2 connectors.
Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection because carton labels and product inserts incorrectly state the amount of the excipient edetate disodium (EDTA).
Access Scientific LLC is recalling 1,710 Powerwand XL kits due to incorrect catheter length labels. The error may cause treatment delays or user annoyance.
VistaPharm is recalling Nystatin Oral Suspension because an impurity peak exceeded approved specifications. The affected product is distributed in the United States and Puerto Rico.
VistaPharm is recalling Nystatin Oral Suspension cups because an impurity peak exceeded approved specifications. The recall covers 380,700 cups distributed in the United States and Puerto Rico.
Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.
Somerset Therapeutics is recalling 383,437 bottles of Brimonidine Tartrate Ophthalmic Solution 0.2% because a slow leaching process from the product label may impact the product over its shelf life.
Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.
Biogen MA Inc. is recalling 3,922 bottles of Tecfidera (dimethyl fumarate) 240 mg capsules because a rejected lot was distributed to US markets.
Rising Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to a carton label mix-up where 0.25% bottles were shipped in 0.5% cartons.
American Health Packaging is recalling 265 cartons of Nabumetone Tablets because the carton label did not include the required statement to dispense with the accompanying Medication Guide.
Stumptown Coffee Corp is recalling 900 units of Cold Brew Coffee and Chocolate with Oatmilk due to packaging failure causing leakage.
Rising Pharmaceuticals is recalling 15,072 bottles of Timolol Maleate 0.25% ophthalmic solution because some outer cartons were mislabeled as 0.5% strength.
Utak Laboratories is recalling 1,395 vials of NR Trace Elements Serum Control due to incorrect cadmium reference values and expected ranges.
Pfizer is recalling Duavee tablets because they failed to meet dissolution specifications. The recall covers 544,400 packages distributed nationwide.
Volkswagen is recalling two 2018 Golf GTI vehicles because the VIN on the Federal Certification label may not match the actual vehicle VIN, potentially preventing owners from identifying safety recalls.
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 7.5 mg, because the product failed impurity and degradation specifications.
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, because the product failed impurities and degradation specifications.
Abbott Vascular is recalling 13 units of Xience Sierra coronary stents because they bear an incorrect expiration date.
Unichem Pharmaceuticals is recalling Clonidine Hydrochloride tablets due to potential benzophenone migration from containers.
Akorn, Inc. is recalling specific lots of Prednisolone Sodium Phosphate Oral Solution because the product failed a color test.
PerkinElmer is recalling 226 Sample Collection Devices because the serial numbers on the pack labels did not match the devices inside.
Boston Scientific is voluntarily removing certain spinal cord stimulation leads and extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Jubilant Cadista Pharmaceuticals is recalling Lamotrigine Tablets, 150 mg, due to the presence of foreign silica granules consistent with desiccant pack material.