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.
Equibal Inc. is recalling Blemfree All Day Lotion due to manufacturing deviations from Current Good Manufacturing Practices. The product was distributed nationwide via internet sales.
Rising Pharma is recalling 868 tubes of Diflorasone Diacetate ointment because impurity levels failed to meet safety specifications during stability testing. No illnesses have been reported.
Penn Herb Company is recalling Nature's Wonderland brand Thyroid Formula due to potential Salmonella contamination. Fifty-one bottles were distributed across nine states.
Integrity Products recalls RAM IT Horny Goat Weed dietary supplement capsules nationwide because they contain undeclared sildenafil, a prescription drug not listed on the label.
To the Moon Capsules are being recalled nationwide because they contain undeclared sildenafil, a prescription pharmaceutical. The product was marketed without FDA approval.
Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.
Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 12 and older.
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
Walmart Great Value Organic Black Chia Seeds (32 oz) are being recalled due to potential Salmonella contamination. The product was distributed to multiple states.
Italiamo brand frozen Eggplant Parmesan may contain undeclared wheat and milk allergens. Foreign language labeling prevented proper allergen disclosure.
Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.
Dr. Reddy's Laboratories is recalling Allopurinol 300mg tablets due to the presence of a foreign substance. Approximately 20,520 units were distributed in Illinois, Mississippi, and Ohio.
Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.
Breadbox Co. is recalling Breadman Raisin Bread due to undeclared milk allergen and Yellow No. 5. Affected units were distributed to retail locations in Southern California.
Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.
Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.
Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.
Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.
Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.
Stryker Corporation recalled Non-Sterile Flyte hood protective covers that were distributed expired. The affected medical device units may not function as intended.
Grande Ingredients has recalled lactose and lactose powder products due to potential Salmonella contamination. No illnesses have been reported.
SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.
Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.
First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.
Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.