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.
Heartware recalls HVAD ventricular assist pump instructions to clarify controller fault alarm conditions and component useful life expectations.
Wilson-Cook Medical is recalling 157 Quantum TTC Biliary Balloon Dilator devices due to a design defect that may cause balloon detachment during use, potentially requiring emergency retrieval.
Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.
Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.
Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
BAPS Shayona is recalling approximately 674 units of Motichur Ladoo across six states due to undeclared Yellow #5 and Yellow #6 food dyes discovered during an FDA inspection.
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.
Right Value Drug Stores is recalling LET Gel topical anesthetic syringes nationwide due to incorrect product formulation. Patients should not use affected syringes and should consult their healthcare provider.
Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.
Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.
BAPS Shayona is recalling Badam Pista Sandwich due to undeclared Yellow #5 and Green 3 color additives. The product was distributed to six states.
Le Croissant Chicken Salad (5.8 oz, sold as Jack & Olive, Sprig & Sprout, or Food Unlimited) has been recalled due to undeclared milk and soy allergens. Approximately 4,146 units were distributed across 15 states and Washington D.C.
Botanical Be is recalling Kuka Flex Forte caplets nationwide because they contain undeclared diclofenac and were marketed without required FDA approval. All lots expire 12/12/2024.
Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.
Le Croissant Tuna Salad (5.8oz) is recalled due to undeclared milk and soy allergens. Consumers with allergies to these allergens should not consume the product.
GreenGate Fresh Cello Spinach is being recalled due to potential E. coli (EHEC) contamination. The recall involves 11 cases distributed to eight consignees across seven U.S. states.
Eltahan Inc. is recalling Eltahan Golden Raisins (400g, UPC 2337660022) distributed in NY, NJ, and PA due to undeclared sulfites, which can cause severe allergic reactions.
Botanical Be is recalling 235 bottles of Artri King tablets sold nationwide. The tablets contain undeclared diclofenac and were marketed without FDA drug approval.
Reumo Flex caplets packaged in 30-count boxes are being recalled because they contain undeclared diclofenac and were marketed without FDA approval. The product was distributed nationwide.
Apotex Corp. is recalling Paroxetine 10 mg tablets nationwide due to out-of-specification impurities in an excipient. Affected lots expire 08/2024.