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.
Roche Molecular Systems is recalling 194 cobas Liat Influenza A/B Quality Control Kits because they are labeled with incorrect expiration dates.
Apotex Scientific is recalling specific lots of Duloxetine Delayed-Release Capsules because they failed dissolution specifications during stability testing.
Apotex Scientific is recalling Duloxetine Delayed-Release Capsules because stability testing revealed out-of-specification dissolution results.
West-Ward Columbus Inc. is recalling 1,182 bottles of Oxycodone Hydrochloride Oral Solution due to failed impurities and degradation specifications.
Ortho-Clinical Diagnostics is recalling 30 enGen Laboratory Automation Systems due to a software error that displays incorrect interpretive text for certain test results.
GSK Consumer Healthcare is recalling Breathe Right Clear nasal strips because some secondary packaging cartons were incorrectly labeled for the AU/NZ market.
Golden State Medical Supply is recalling 2,077 bottles of Duloxetine 60 mg capsules because the container labels display an incorrect expiration date.
Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.
Exactech is recalling 8 units of Novation Press-Fit Splined Femoral Stems because they are labeled with an incorrect Global Trade Item Number (GTIN).
Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 29 because incorrect calibration mathematics may cause biased test results for total iron-binding capacity.
KVK-Tech, Inc. is recalling specific lots of Benzphetamine Hydrochloride Tablets due to cosmetic scuffing marks on the tablets.
Dr. Reddy's is recalling CVS pharmacy Acid Controller tablets because stability testing revealed an out-of-specification impurity.
Valeant Pharmaceuticals is recalling 958 bottles of SECONAL SODIUM capsules because the package insert is missing a warning regarding anaphylaxis.
Aidarex Pharmaceuticals is recalling 599 bottles of Ciprofloxacin Ophthalmic Solution because testing revealed out-of-specification results for an unknown impurity.
Cardiovascular Systems Inc is recalling ViperWire Advance Peripheral Guide Wire because the pouch label was missing the use-by date.
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because an incorrect lot number appears on the case label.
Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules because testing revealed out-of-specification results for a known impurity.
Virtus Pharmaceuticals is recalling 1,586 bottles of VP-CH-PNV Prenatal/Postnatal capsules because the softgel capsules are leaking.
Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate Sublingual Tablets because bottles may contain broken dessicants.
Attix Pharmaceuticals is recalling Mycophenolate Mofetil bulk powder due to cGMP deviations and lack of FDA registration.
Leica Biosystems Richmond Inc. is recalling 283 CytoVision Image Analysis and Capture Systems because the Windows 7 operating system is improperly activated, appearing unlicensed.
Sandoz Inc is recalling 3,048 bottles of Lisinopril Tablets USP, 30 mg, because the package insert is incorrect or missing.
CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Synthes (USA) Products LLC is recalling six LCP Dia-Meta Volar Distal Radius Plates because the preprinted outer boxes were incorrect, though the internal product labels are accurate.