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.
Mylan Institutional is recalling 1,664 cartons of levothyroxine sodium tablets nationwide due to potency variance. The tablets contain subpotent and superpotent units, affecting the consistency of each dose.
7-Eleven Chicken Salad Sandwiches (UPC 7 63913-79486 1) are mislabeled and actually contain tuna salad. The product poses a risk to consumers with tuna allergies.
Micro-X Ltd. is recalling 18 MICRO-X Rover Mobile X-ray Systems because they can deliver lower radiation doses than operators set. The affected units use Control Board PCBA 12425-03 or earlier.
Sysco Corporation is recalling Cucumber Chunk & Tomato Wedge products due to potential Salmonella contamination in cucumbers. Products were distributed in Iowa, Minnesota, South Dakota, North Dakota, Wisconsin, and Canada.
Super Brand Dried Cinnamon Powder (4 oz) distributed across nine states is being recalled due to elevated lead levels. Consumers should discard purchased containers.
Mckesson Medical-Surgical Inc. is recalling HYLENEX RECOMBINANT (hyaluronidase) injection due to cGMP deviations involving a temperature excursion during storage, which may have compromised drug potency.
Viatris Inc. is recalling Levothyroxine Sodium 200 mcg tablets nationwide due to potency failures—some tablets are superpotent while others are subpotent. Affected lots expire July 2025; patients should contact their healthcare provider.
Mylan Institutional is recalling Levothyroxine Sodium tablets nationwide due to subpotent and superpotent units. Patients taking affected tablets may receive incorrect doses of this thyroid medication.
Giant Eagle churned Butter Pecan Reduced Fat ice cream is being recalled because it contains undeclared soy (soy lecithin), posing a risk to consumers with soy allergies.
Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.
Mylan Institutional is recalling 2,835 cartons of Levothyroxine Sodium 100 mcg tablets nationwide due to potency deviations—some tablets may be underdosed while others may be overdosed.
The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.
Biocompatibles is recalling 432 Varithena (polidocanol injectable foam) Administration Packs due to incorrect syringe connectors. The packs contain luer lock syringes instead of the required luer slip connection syringes.
Hologic is recalling 178 units of Sizer Set surgical instruments nationwide because instructions for use and revised sterilization instructions were not provided with the product.
Nestle Health Science recalls Nutren 2.0 pouches mislabeled as Isosource 1.5. The labeling error affected 5,754 units distributed across 16 states.
ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.
LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.
Dr. Reddy's Laboratories is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) tablets nationwide because the medication failed specifications for impurities and degradation products. Affected patients should contact their healthcare provider.
Small DKS Disposable Kerrison System instrument sets were inadvertently distributed when not intended for commercial distribution. Six sets (Lot 1578) were distributed to Kansas, Louisiana, Michigan, New York, and Texas.
Albertsons Companies LLC recalls multiple ready-meal salad products due to Listeria monocytogenes contamination in cooked chicken. Products were distributed across 21 US states with sell-through dates through October 13, 2024.
VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.
Fresh Express Gourmet Cafe Chicken Caesar salad bowls are being recalled due to potential Listeria monocytogenes contamination linked to a Bruce Pac recall. The recall affects products distributed across multiple U.S. states.
Fresh Express Gourmet Cafe Santa Fe Greek salad bowls are being recalled due to potential Listeria monocytogenes contamination linked to a chicken ingredient recall. No illnesses have been reported.
Wegmans Large Asian Sesame Salad with Chicken contains undeclared egg, a common allergen. The recall affects 365 units distributed across nine states.
ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.