Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Prospector Popcorn is recalling Belgian Chocolate Toffee Gourmet Popcorn due to inaccurate nutrient declarations for Iron and Vitamin D.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
Prospector Popcorn is recalling 21,400 units of Maple Walnut Ice Cream Gourmet Popcorn due to inaccurate nutrient declarations for potassium, calcium, and iron.
BMC Medical is recalling 20,160 Luna G3 APAP devices to report 2024 rework conducted at a warehouse.
FlavorsandColor.Com is recalling 80 cases of Honeyville Yellow Color 1 Gallon due to undeclared Red #40. The product was distributed to 12 locations in four states.
Siemens Healthcare Diagnostics is recalling Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1 due to out-of-specification sodium azide concentration.
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (150 mg) because testing showed impurities exceeded established limits during stability testing.
Ascend Laboratories is recalling dabigatran etexilate capsules due to an out-of-specification result in related substance testing involving Impurity II, Impurity III, and total impurities observed during 12-month stability testing.
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (75 mg) because testing showed impurities exceeded established limits during stability testing.
Boston Scientific recalls cardiac ablation generators due to incomplete Instructions For Use that omit information about a compatible catheter.
Asclemed USA Inc. is recalling 18 Lidolog Kits because the label wrap covers the barcode, making it hard to scan. The recall affects products distributed within the U.S. in Tennessee.
Shandong Ling Xian Food Co., LTD is recalling Island Pacific Imitation Crab Flakes because they contain undeclared sodium tripolyphosphate.
Island Pacific imitation crab sticks are being recalled because they contain undeclared sodium tripolyphosphate.
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed dissolution specifications. The recall covers 15,853 bottles distributed nationwide.
Imitation crab sticks made by Shandong Ling Xian Food Co., LTD are being recalled because they contain undeclared sodium tripolyphosphate (STTP), a food additive not listed on the product label.
3B Medical, Inc. is recalling Rio II Nasal Pillows Interface devices due to packaging and labeling discrepancies involving product size identification and device identifiers. The affected models are RII1001 (Small), RII1002 (Medium), and RII1003 (Large).
Ember is recalling 2027 E-Series, Touring, and Overland travel trailers because the Federal Certification Label may list the wrong VIN, which could prevent owners from recognizing safety recalls.
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Fexofenadine Hydrochloride Tablets, USP 180 mg distributed nationwide because the product failed impurities and degradation specifications. The recall affects approximately 9,048 bottles distributed across the United States.
ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution due to the presence of a foreign substance. The affected lot is S25133A, distributed nationwide.
Produce Innovations is recalling roast beef and cheddar closed-face sandwiches that are labeled as turkey and cheddar. The mislabeling may pose a risk to consumers with turkey allergies.
United Salt Corp is recalling salt because plain salt was labeled as iodized and iodized salt was labeled as plain, a mislabeling issue.
Focalin XR 5 mg extended-release capsules are being recalled over a labeling issue: incorrect or missing lot number and/or expiry date. 7,803 bottles are affected.
Amerisource Health Services LLC is recalling Primidone 250 mg tablets (Lot 1027583, expiration 09/30/2027) due to cross-contamination with trace amounts of Acemetacin API during manufacturing.
Amerisource Health Services LLC is recalling Primidone Tablets 50 mg due to cross-contamination of the active ingredient with trace amounts of Acemetacin API. The recall affects 225,000 tablets distributed nationwide.
Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots were distributed nationwide.