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.
Vi-Jon is recalling Citroma magnesium citrate oral laxative due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed nationwide and internationally.
Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.
Magnesium citrate saline laxative products branded as CITROMA and multiple retail equivalents are subject to a Class II recall due to manufacturing process deviations. The voluntary recall affects millions of bottles distributed nationwide and internationally.
PTS Panels CHOL+GLU Test Strips (lot A202) are recalled because incorrect instructions for use were packaged with the product. Distribution includes the US, Japan, and Russia.
Vi-Jon, LLC voluntarily recalled Magnesium Citrate Saline Laxative due to manufacturing process deviations. Over 8 million units of the product were distributed nationwide.
Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.
Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
Select Bakery has recalled its Old Fashion Chocolate Creme Cake for containing undeclared soy. The recall affects products distributed in Georgia, North Carolina, and South Carolina.
Kent Precision Foods Group is recalling Thick-It Original Food & Beverage Thickener due to possible insanitary conditions during manufacturing. The product was distributed to food service facilities including hospitals and nursing homes.
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
Select Bakery's 3-oz Orange Creme Cake is recalled for undeclared soy. The product was voluntarily recalled and distributed to Georgia, North Carolina, and South Carolina.
Plastikon Healthcare LLC is recalling multiple lots of antacid suspension because manufacturing processes were not adequately controlled. The product was distributed nationwide to institutions.
About 7,700 Tethrd One Stick GEN 2 climbing sticks are being recalled because their steps can crack and break under pressure, creating fall and injury hazards. The manufacturer has received five reports of step breakage but no injuries have been reported.
LEM Products Distribution is recalling about 15,900 Roots & Harvest Wide Mouth Pint Canning Jars because pieces of glass may be found inside, posing a laceration hazard. No injuries have been reported.
Hearing Lab Technology/Lucid Audio is recalling approximately 31,150 Children's HearMuffs sound compression ear muffs because the AAA alkaline batteries included can rupture, posing hearing, projectile, and burn injury risks. No injuries have been reported.
Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution due to identification of an unknown impurity during 12-month stability testing. No illnesses have been reported.
Sunset Farm Foods is recalling approximately 4,480 pounds of smoked sausage products that may contain thin blue plastic.
Luxury 70% Isopropyl Alcohol distributed in Virginia by TSM Brands LLC contains undeclared ethyl alcohol, creating a mislabeling hazard. Consumers should stop using the product.
Oxford Immunotec is recalling 6 units of AIM-V Medium (Lot 100380) distributed in seven U.S. states due to equipment failure causing storage outside the validated 2-8°C temperature range for longer than the validated duration.
Padagis US LLC is recalling 57,816 tubes of Triamcinolone Acetonide Cream 0.1% nationwide due to manufacturing process deviations. Consumers reported gritty texture and reduced effectiveness.
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE ADVANCED ICY FRESH is recalled due to improper temperature storage during manufacturing. Approximately 1,680 packages distributed across 11 U.S. states are affected.
Family Dollar Stores recalls 1,400 packages of Colgate Anticavity Fluoride Toothpaste due to improper temperature storage conditions during manufacturing. The product may not meet quality standards.
CVS Pharmacy is recalling Nighttime Sleep-Aid tablets because the carton incorrectly identifies the active ingredient as doxylamine succinate HCl instead of doxylamine succinate. Approximately 257,064 cartons were distributed nationwide.