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.
Glenmark Pharmaceuticals is recalling Ranolazine Extended-Release 1000mg tablets (Lot 17240040) nationwide due to manufacturing deviations. This is a voluntary, firm-initiated recall.
Glenmark Pharmaceuticals is recalling Saxagliptin 2.5mg tablets nationwide due to manufacturing quality issues. The firm initiated this voluntary recall on March 13, 2025.
Glenmark Pharmaceuticals is voluntarily recalling Pravastatin Sodium 80mg tablets due to Current Good Manufacturing Practice deviations. The nationwide recall affects specific lot numbers and remains ongoing.
Glenmark Pharmaceuticals is voluntarily recalling Cetirizine HCL 10mg tablets distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice deviations.
Glenmark Pharmaceuticals is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lot numbers expiring February through June 2026.
Asegua Therapeutics is recalling 18,541 cartons of Sofosbuvir and Velpatasvir tablets nationwide due to defective blister packs that are not properly sealed, resulting in loose tablets in cartons. No illnesses or injuries have been reported.
Choshiya branded menma (prepared bamboo shoots) are being recalled because the label fails to include the required 'Keep Refrigerated' statement. Improper storage of this non-shelf-stable product could lead to foodborne illness.
AKT Trading Inc. is recalling Choshiya branded Shiba Zuke Prepared Mix Vegetables (1,000 cases) because they are missing the required "Keep Refrigerated" statement on the label. Non-shelf stable vegetables could be improperly stored without this critical labeling information.
AKT Trading Inc. is recalling Choshiya branded Soft Tsubozuke Prepared Mix Vegetables due to missing "Keep Refrigerated" statement on labels. Non-shelf stable vegetables lacking this statement may spoil or develop harmful bacteria if stored improperly.
Choshiya brand rakkyo zuke prepared vegetables are being recalled due to missing 'Keep Refrigerated' label statements. These non-shelf-stable vegetables may spoil if not properly refrigerated.
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex (P)2 due to the potential for cracks to form in the breathing circuit hose. This FDA Class I recall affects approximately 9,250 units distributed domestically and internationally.
Draeger, Inc. is recalling 65,150 units of the VentStar Flex 220 breathing circuit due to the potential for cracks to form in the hose. A crack could affect gas delivery during anesthesia or ventilation procedures.
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 6 (Model MP02744) due to potential cracks forming in the breathing circuit hose. Approximately 293,660 units were distributed nationwide and internationally.
Frito-Lay is recalling 1,295 bags of Tostitos Cantina Traditional Yellow Corn Tortilla Chips because milk was not declared on the label. Affected products were distributed across 13 states.
Draeger is recalling the Anesthesia Circuit Kit Flex EPA due to the potential for cracks to form in the breathing circuit hose. Approximately 13,620 units have been distributed domestically and internationally. Users should discontinue use of affected units immediately.
AKT Trading Inc. is recalling Choshiya branded Fukushin Zuke Prepared Mix Vegetables due to a labeling deficiency. The non-shelf-stable product is missing the required "Keep Refrigerated" statement.
Draeger's ID Circuit Flex 220 breathing circuit for anesthesia machines may develop cracks in the hose. The recall affects 3,325 units distributed nationwide and internationally.
AKT Trading Inc. is recalling Choshiya branded Aokappa Zuke Prepared Mix Vegetables because the product label lacks a 'Keep Refrigerated' statement, risking improper storage of non-shelf-stable vegetables.
Draeger's Anesthesia Circuit Kit Flex 2 is recalled because of the potential for cracks to form in the breathing circuit hose. No injuries have been reported.
Draeger, Inc. is recalling Anesthesia Circuit Kit Flex 1 devices nationwide and internationally due to potential cracks in the breathing circuit hose that conducts anesthesia gases.
Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.
SeaBear Smokedhouse Salmon Chowder is recalled due to potential seal failure that could allow Clostridium botulinum contamination. The recall affects 11,152 pouches distributed nationwide.
Biocon Pharma is recalling 2,184 bottles of Atorvastatin Calcium Tablets USP 40 mg nationwide. The product failed to meet required dissolution specifications, which may affect medication absorption.
BD Connecta Luer-Lok 360 stopcocks were distributed with non-U.S. instructions for use. Healthcare facilities should verify they have the correct U.S. instructions before using affected lot numbers.
GE Healthcare's Centricity medical imaging software has a security vulnerability that allows service login credentials to be identified. A malicious actor could exploit this to access or manipulate patient data.