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.
Advanced Back Technologies is recalling 18 Extentrac Elite User Manuals because they incorrectly state the device is for patients up to 350 lbs, while the device is only approved for up to 300 lbs.
Orthofix is recalling Firebird Spinal Fixation System screws because the length marking on the tip is incorrect.
Pharmatech LLC is recalling Rugby Poly Vitamin Liquid with Iron because the outside packaging labels may not match the individual product labeling, potentially displaying incorrect lot, expiration, or product identity information.
Nuevotanicals is recalling Kratom (Kr8om) MD Oil products because they contain Kratom. The recall covers units distributed across 12 states.
SCA Pharmaceuticals is recalling 50 bags of phenylephrine HCl 50 mg in 0.9% sodium chloride due to a label mix-up. The product was incorrectly labeled instead of phenylephrine in 5% dextrose.
Nuevotanicals is recalling unlabeled Kratom leaf powder products because they contain Kratom.
GE OEC Medical Systems is recalling nine mobile X-ray laser aimer assemblies because they were shipped without required laser product certification.
Ortho-Clinical Diagnostics is recalling VITROS Urine Assay Data Disks because a software error may allow samples requiring acidified pretreatment to be metered from the same container as those requiring no pretreatment.
Valeant Pharmaceuticals is recalling Nifedipine Extended-Release Tablets, 90 mg, because some lots failed dissolution specifications.
Nuevotanicals is recalling Kratom Maeng Da Thai Pure Alkaloid Suspension Oil because the products contain Kratom.
Akorn, Inc. is recalling 424,174 bottles of Hydroxyzine Hydrochloride oral solution because the product failed impurities and degradation specifications.
Pinnacle Foods is recalling approximately 668,316 pounds of Swanson Stuffing Baked Turkey dinners because the product contains monosodium glutamate (MSG) that is not declared on the label.
Mallinckrodt is recalling 6,600 bottles of MD Gastroview because some bottles have incorrect or missing lot numbers and expiration dates.
Nuevotanicals is recalling K SHOT botanical supplement shots because the products contain Kratom. The recall affects 10,000 units distributed across 12 states.
Advanced Back Technologies is recalling 36 Extentrac Elite powered decompression tables because the product brochure incorrectly states a 350-lb weight limit, while the device is only approved for patients up to 300 lbs.
The FDA is recalling 77 kg of unlabeled Green Malay Kratom bulk product in 1-gallon jugs due to the presence of Kratom.
Becton Dickinson is recalling BBL Port A Cul tubes because excessive oxidation may affect the viability of anaerobic microorganisms.
Roxy Trading Inc. is recalling Seasoning Fish Filet because the label incorrectly identifies the fish as Grouper and omits the full ingredient list.
Nuevotanicals is recalling 326 kg of unlabeled Kratom powder in 500 g freezer bags distributed to 12 states.
Pharmatech LLC is recalling Rugby Poly Vitamin Liquid, 50ml, because the outside packaging may have incorrect lot, expiration, or product identity information.
Compass Health Brands is recalling 219,353 Roscoe Mini Neb Compressor user manuals to add warnings about proper handling and storage to reduce power cord damage.
Larry's Custom Meats Inc. is recalling beef tongue products that may contain lingual tonsils, which are specified risk materials for BSE.
Medtech Products is recalling Sucrets Sore Throat & Cough Vapor Cherry lozenges because an incorrect book label was applied to the tins.
Edwards Lifesciences is recalling 978 Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters because they failed internal statistical tests for heparin activity.
Mylan Pharmaceuticals is recalling 7,722 bottles of Mycophenolic Acid Delayed-release Tablets, 180 mg, because they failed to meet dissolution specifications.