Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Flowers Foods is recalling Tastykake Glazed Caramel Apple Pie because some packages contain undeclared soy lecithin, a major food allergen. Consumers with soy allergies should not consume this product.
ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.
Lyons Magnus is recalling Imperial Thickened Cranberry Cocktail Nectar due to indication of product spoilage. Approximately 2094 cases were distributed nationwide.
Karlsburger Kitchens NSLP 140 Turkey Gravy Mix labeled as gluten-free contains undeclared gluten. The product was distributed in Kansas, Minnesota, Nebraska, and Wisconsin.
B. Braun is recalling CARESITE SMALLBORE EXT SET T-PORT 5 IN. devices due to potential bonded joint failure that could cause leakage or detachment during use. The malfunction may result in delayed therapy, bloodstream infection risk, and exposure to hazardous medications.
Market Pantry White Fudge Animal Cookies sold at Target may contain metal fragments. D. F. Stauffer Biscuit Co is recalling 883 cases distributed nationwide.
Seeking Health LLC is recalling Optimal Multivitamin Chewable Dietary Supplement tablets because lab testing found higher copper levels than stated on the label.
Lyons Magnus is recalling Imperial Thickened Cranberry Cocktail Honey due to indication of product spoilage. Consumers who have purchased affected cases should stop using the product.
Flowers Foods is recalling Mrs. Freshley's Cherry Fruit Pie due to undeclared soy lecithin. Soy is a major allergen; consumers with soy allergies should not consume the product.
Nick's Krispi Nougat Protein Bar is being recalled because the product contains hazelnuts that are not declared on the label. This poses a risk to consumers with tree nut allergies.
AuroMedics Pharma is recalling Acyclovir Sodium injection due to dark red, brown, and black particulate matter found in vials. Approximately 89,400 vials were distributed nationwide.
Lyons Magnus LLC is recalling Lyons Ready Care Thickened Apple Juice due to indication of product spoilage. The recall affects 320 cases distributed nationwide.
Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.
B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.
The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.
Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The syringes do not meet raw material specifications.
Intersurgical Solus Standard size 3 laryngeal mask airways are marked with incorrect size 4 information, which may cause misuse or improper sizing of the airway device.
Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.
Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 300 mg, because samples exceeded acceptable limits for 1-Methyl-4-Nitrosopoperazine (MNP), an impurity. Multiple lot numbers were distributed nationwide.
Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.
Tuscan Garden Restaurant Style Italian Dressing is being recalled due to undeclared soy and wheat allergens. The recall affects 26,370 mixed cases distributed across 20 states.
BD Vacutainer blood collection tubes are recalled due to isobutylene contamination that may cause false positive results in blood alcohol testing.
Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection distributed nationwide due to lack of assurance of sterility and potential leakage. Multiple lot numbers with expiration dates ranging from May 2023 to August 2023 are affected.
Trader Joe's Organic Yellow Tortilla Chip Rounds may contain undeclared milk and soy allergens. The product contains small amounts of Spicy Cheese Crunchies which were not listed on the label.