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.
Sandoz Inc is recalling specific lots of Nitrofurantoin capsules because they may be cross-contaminated with other products.
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Lipase Flex Reagent Cartridges due to lot-to-lot variability in quality control and patient results.
Aldi is recalling Millville Maple & Brown Sugar Instant Oatmeal because of complaints of insects in the product. The recall affects 37,200 units sold in 17 states.
GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.
Qiagen is recalling 298 EZ1 Advanced XL instruments due to a power board defect that may cause heater malfunctions and compromise nucleic acid extractions.
Baxter Healthcare is recalling 402,165 vials of Metoprolol Tartrate Injection because the solution's pH shifted upward during shelf life.
Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream in Toasted Coconut flavor because soy oil was not declared on the label.
Campofresco Corp. is recalling Orange plus Citrus Beverage from Concentrate because it may be contaminated with a sanitizing solution. The affected product was distributed to US consignees.
Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream Vegan Coconut because soy oil was not declared on the package label.
Randox Laboratories is recalling Liquid Cardiac Control CQ5051 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
S.C. Johnson Professional is recalling 258 cases of Alcohol Free Foaming Hand Sanitizer because the product was released to market prior to microbiological testing.
DT MedTech is recalling specific talar implants for ankle joints because the package labels incorrectly identify the device.
Safe N Simple, LLC is recalling 125 cases of Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified. The affected products were distributed in California.
Randox Laboratories is recalling Liquid Cardiac Control CQ5053 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
Medtronic Navigation is recalling 641 O-arm 02 Imaging Systems to correct software version 4.1.0, update manuals and labels, and replace blown fuses in the AC power input circuit.
Janssen Pharmaceuticals is recalling Ortho-Novum 1/35 tablets because the packaging included instructions for the wrong type of pill dispenser.
Medline Industries is recalling SparkleFresh fluoride toothpaste nationwide due to microbial contamination of the non-sterile product.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Reagent Packs due to a potential for increased calibration failures.
Integrity Implants is correcting Instructions for Use for the FlareHawk Interbody Fusion System due to discrepancies in cleaning parameters.
S.C. Johnson Professional is recalling 869 cases of Deb Stoko Refresh AntiBac Foam because the product was released to market before microbiological testing was completed.
DT MedTech is recalling 54 units of Hintermann Series H3 Poly Inlays because the package labeling incorrectly identifies the device.
Safe N Simple, LLC is recalling Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified.
Janssen Pharmaceuticals is recalling Ortho-Novum 7/7/7 tablets because the packaging included instructions for the wrong type of pill dispenser.
Silver Star Brands is recalling Healthful Naturals Leg Cramp Support Oral Spray due to manufacturing deviations that could result in possible microbial contamination.
Tailor Made Compounding is recalling 10,280 vials of Tesamorelin because the labels indicate a 1-year expiration date instead of the correct 6-month date.