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.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension because product complaints indicated the reconstituted suspension was observed to be thick.
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.
Lupin Pharmaceuticals is recalling specific lots of Nitrofurantoin Oral Suspension because the drug was found to contain less active ingredient than required.
Root 23 LLC is recalling 390 units of Cucumber Habanero Simple Syrup because the temperature at the start of the thermal process was not recorded.
Abbott is recalling 27 units of the Alinity i Total Beta-hCG Reagent Kit because a manufacturing issue may damage bottle necks, causing reagent loading failures on the instrument.
Howmedica Osteonics Corp. is recalling HydroSet XT Injectable HA Bone Cement because the product labels display an incorrect expiry date.
Abbott is recalling 294 units of Alinity i Free T4 Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument loading failures.
Howmedica Osteonics Corp. is recalling HydroSet XT Injectable HA Bone Cement because the product displays an incorrect expiry date of 9-Feb-20 instead of the correct 30-Aug-19.
Abbott is recalling 79 units of Alinity i Estradiol Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.
Abbott is recalling Alinity i TSH Reagent Kits due to a manufacturing issue that may damage bottle necks, potentially causing reagent loading failures on the instrument.
Hologic is recalling 337 I-View Contrast Enhanced Digital Mammography systems due to a calibration issue that prevents visualization of contrast uptake.
Abbott is recalling 157 units of Alinity i Progesterone Reagent Kits due to a manufacturing issue that can cause bottle neck damage and instrument failure.
Abbott is recalling specific lots of Alinity i 25-OH Vitamin D Reagent Kits due to a manufacturing issue that may damage bottle necks and cause instrument failure.
Tosoh Bioscience is recalling 992 units of ST AIA-PACK Homocysteine reagents used for in vitro diagnostic testing. The voluntary recall covers all lots distributed nationwide.
In2bones USA, LLC is recalling NeoSpan SuperElastic Compression Staple kits because they contain a 3mm drill bit instead of the required 2mm bit.
Tosoh Bioscience Inc is recalling AIA-PACK B12 reagents because fluorescein interference may cause inaccurately elevated Vitamin B12 test results.
Amerigen Pharmaceuticals is recalling specific lots of Temozolomide Capsules because they failed to meet dissolution specifications.
Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.
Tosoh Bioscience Inc is voluntarily recalling 1,085 units of ST AIA-PACK ACTH in vitro diagnostic reagents distributed nationwide in the US.
Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Clark Laboratories is recalling 463 units of Genesys Diluent Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Luckyberry is recalling unpasteurized cold-pressed juice products because they were manufactured and distributed in violation of FDA regulations.
Diagnostica Stago is recalling Staclot LA test kits because some results showed shortened times, potentially affecting lupus anticoagulant detection accuracy.