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.
LGM Pharma LLC is recalling 1,307 kg of Thyroid Powder, USP, because the product has inconsistent levels of active ingredients levothyroxine and liothyronine.
CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.
Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.
Zimmer Biomet is recalling specific lots of the Orthopedic Salvage System Porous Stem because the Mini Humeral Stem may be mislabeled as the Bowed IM Stem.
The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.
Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.
CAO Group, Inc. is recalling fas.TRACT Coagulative Hemostatic Gel kits due to current Good Manufacturing Practice (cGMP) violations identified during a recent inspection.
CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.
Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.
Philips is recalling IntelliVue MX40 patient monitors because the speaker volume may be diminished or inaudible at altitudes above 4,500 feet.
CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.
CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
Vermont Packinghouse is recalling raw bone-in beef quarters from cattle over 30 months old due to possible specified risk materials contamination.
Frutarom USA Inc. is recalling 1,018 bottles of Sebastiano's French Vanilla syrup because the product contains sugar despite being labeled 'Naturally Sugar Free.'
Pfizer is recalling Thermacare Muscle Pain Therapy HeatWraps because the wraps may come apart and leak granular material.
Fresenius Kabi is recalling 23.7 million sodium chloride vials because labels incorrectly state the stoppers do not contain natural rubber latex.
Fresenius Kabi is recalling 1,312,350 vials of Sodium Chloride Injection because labels incorrectly state the stoppers do not contain natural rubber latex.
NOW Foods is voluntarily recalling 61 bottles of Vitamin B-50 Complex with C 100 Veg Caps because they are mislabeled as Vitamin B-50 mg 100 Veg Caps.
Tillamook County Creamery is recalling Chocolaty Chip Cookie Dough ice cream because it contains undeclared color additives Amaranth and Yellow No. 6.
Tillamook is recalling Udderly Chocolate ice cream because it contains trace amounts of undeclared color additives Amaranth and Yellow No. 6.
Black River Industries is recalling Sweet Basil Leaf in 2 lb. bottles and 25 lb. boxes because it may contain plastic foreign material.
Black River Industries is recalling Parsley Flakes because they may contain plastic foreign material. The recall also includes Basil Leaf Sweet and Italian Spice Blend No Salt.
Pfizer is recalling Thermacare HeatWraps Menstrual because the wraps may come apart and leak granular material.
Tillamook Mudslide ice cream is recalled because it contains trace amounts of undeclared color additives Amaranth and Yellow No. 6.
Titan Farms is recalling 192 cases of Tickled PEACHES Freestone Dices due to the presence of foreign plastic material.