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.
AVKARE Inc. is recalling Phytonadione Tablets 5 mg because the impurity degradant D level failed to meet specification. The affected lot was distributed in Los Angeles, California.
Johnson & Johnson Vision Care is recalling certain ACUVUE VITA soft contact lenses due to potential incomplete packaging seals. Only a limited number of packages from LOT # BOOWWWL are affected.
Prisma Health Outsourcing Facility is recalling Ketamine HCl Injection Solution (10 mg / 2 mL) distributed in South Carolina due to incorrect expiration dates and incorrect Beyond Use Dates (BUD) on the labeling.
World Source LLC is recalling QiYu Hand Sanitizer Gel (500 mL bottles) distributed to two hospitals in New York because the product is subpotent—meaning it contains less active ingredient than specified.
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable specifications.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (Lot #20PU04030, 4 cases) distributed nationwide because the product was exposed to temperatures outside specified limits, which may affect safety and efficacy.
Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.
McKesson Corporation is recalling Levetiracetam Tablets USP 250 mg due to a barcode error that could cause some units to be misread as Naproxen 500 mg, although the product label itself is correct.
Fresenius Medical Care is recalling 285 cases of DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution.
Kerry Inc. is recalling Concentrated Creamy Alfredo Sauce (product code 20608306, lot 4771420) because it was made with a non-food-grade anti-foamer ingredient.
The Coca-Cola Company is recalling Glaceau Vitaminwater XXX acai-blueberry-pomegranate labeled as zero sugar because an incorrect label was used and the product may actually contain sugar.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.
MICROVENTION INC. is recalling VIA Microcatheter units that were inadvertently shipped with international labeling instead of US-cleared labeling. Units were distributed in six U.S. states.
RC Industries Inc. is recalling Mideo's Marinara Glass 32oz jars because the potassium content listed on the label does not match the actual amount per serving.
Kerry Inc. is recalling Garlic Alfredo Sauce (product code 20607981) because the product was manufactured with a non-food grade anti-foamer ingredient. The affected sauce was distributed to AZ, CO, OK, TX, and WI.
Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution, which may compromise sterility or safety.
Medline Industries is recalling READYPREP CHG 2% Chlorhexidine Gluconate Cloth because the product contains higher-than-specified levels of the active ingredient.
MICROVENTION INC. is recalling VIA Microcatheter VIA 21 units (Lot 19110403M) because they were shipped with international labeling instead of FDA-cleared US labeling.
Terumo is recalling Sarns Temperature Control Monitor units (1,176 devices) because it cannot validate a cleaning protocol meeting current FDA requirements. Users should discontinue use and dispose of affected devices immediately.
Wegmans Food Markets is recalling its 7-pound bagged ice products due to possible contamination with metal fragments. The recall affects products distributed in New York, Massachusetts, and Pennsylvania.
Genpak is recalling Bake n Show Muffin Trays in three sizes due to the discovery of foreign objects in product packaging. The recall affects units distributed across multiple US states and Canada.
Genpak is recalling Bake n Show Angel Food Trays (8-inch and 8-inch shallow models) because foreign objects were found in the product packaging. Consumers should stop using affected trays.
K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants with mislabeled product dimensions. The affected sizes include 10x22x14mm, 10x28x14mm, and 10x22x15mm. No injuries have been reported.
Genpak is recalling Bake n Show Pizza Cookie Trays (12") because foreign objects were found in product packaging. The recall affects multiple states and Canada.