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.
Hormel Foods is recalling Skippy Super Chunk Peanut Butter because aflatoxin levels were slightly above the actionable limit.
LuMaZu, LLC dba Nettle Meadow is recalling 5 oz. Apple Cider Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.
Zimmer Biomet is recalling 31 Dual Mobility Vivacit-E bearings because the outer package label indicates a different size than the implant inside.
Biomet 3i is recalling 10 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.
Ameditech Inc is recalling Alere iCup Drug Detection cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Cardinal Health is recalling pre-operative decolonization kits that contain only one nasal swab instead of the four required for proper treatment.
ev3 Inc. is recalling Pacific Xtreme balloon dilation catheters due to a labeling discrepancy regarding the Rated Burst Pressure value.
Ameditech is recalling 99,900 units of First Check 7 Panel Drug Cups because the products failed to consistently detect all compounds at labeled levels.
Ameditech is recalling ToxCup Drug Screen Cups because they may fail to consistently detect all substances at labeled levels.
Medline Industries is recalling 118 units of Triage BNP calibrators shipped with ice instead of dry ice, risking product degradation.
Ameditech is recalling Alere iScreen Single Drug Detection dip cards because they may fail to consistently detect certain compounds at labeled levels.
Strides Inc. is recalling 11,280 bottles of Potassium Chloride Extended-Release Tablets because they failed to meet dissolution specifications.
Ameditech is recalling Noble 1 Step+ Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.
Ameditech is recalling 47,005 units of First Check 14 Panel Drug Cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.
Hale And Hearty Soups, LLC is recalling 174 bags of Wild Mushroom Barley soup because the product may contain pieces of maggots.
Ameditech is recalling 31,800 units of the Henry Schein One Step + DOA Cup because the immunoassay enzymes failed performance tests, resulting in inconsistent detection of compounds.
Legacy Pharmaceutical Packaging LLC is recalling 111,948 bottles of Metformin Hydrochloride 1000 mg tablets because tablets with different imprints were found in the bottles.
Greiner Bio-One is recalling VACUETTE blood collection tubes because they experienced an issue with separation and clotting.
Ameditech Inc is recalling TDDA Drugs of Abuse Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.
pH-D Feminine Health is recalling Boric Acid Vaginal Suppositories because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Akorn, Inc. is voluntarily recalling 25,843 bottles of Eye Itch Relief eye drops due to CGMP deviations. The product was distributed nationwide in 14 states.
Beckman Coulter is recalling 219 units of UIBC reagent lot 2690 because it produces erroneously high patient results at the low end of the linear range.
Ameditech Inc is recalling 31,600 units of Consult Diagnostics Drugs Abuse Test Cups because immunoassay enzymes failed performance tests, leading to inconsistent detection of compounds.
Siemens Medical Solutions is recalling syngo.CT software versions VB20 and VB20_SP1 for 767 CT systems due to sporadic workflow interruptions that may delay diagnosis or require patient rescans.
Teva Pharmaceuticals USA is recalling Buprenorphine Transdermal Systems because they failed stability specifications for release rate.