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.
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.
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.
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.
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.
BAPS Shayona is recalling Badam Pista Sandwich due to undeclared Yellow #5 and Green 3 color additives. The product was distributed to six states.
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.
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.
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.
Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.
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.
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.
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.
Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.
Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.
Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.
United Packers is recalling Fanta Orange in 12-pack aluminum cans due to potential foreign material. The affected product (Lot No. JUL2924MBD3) was distributed to Alabama, Florida, and Mississippi.
Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.
Breas Medical is recalling 215 mouthpiece units due to manufacturing defects with unintended slits that may result in insufficient ventilation in mechanical ventilation patients.
Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.
Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.
Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.
Food Unlimited Breakfast Sandwich Bacon Egg & Cheddar Croissants are recalled due to undeclared milk and soy allergens. The affected products have Use By dates from 10/27/2023 to 11/8/2023.
24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.