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.
Nature's Energy Children's Chewable Colostrum Berry supplement is recalled because the label does not declare milk allergen, despite containing bovine colostrum. The recall affects consumers with milk allergies.
Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.
Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.
DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.
Viatris Inc. is recalling Levsin injection (hyoscyamine sulfate, 0.5 mg/ml) due to discontinuation of the quality assurance program that verifies product identity, strength, quality, and purity. The recall affects 2,736 boxes distributed to 10 distributors.
Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.
Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.
Procaps is recalling Bacaolinita Liquid Dietary Supplement (8 fl oz bottles) because PEG-40 was not declared on the product label. Consumers should discontinue use.
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.
Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.
Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.
HF Acquisition Co LLC is recalling Glycopyrrolate Injection 0.2mg/mL due to a label mix-up affecting specific lots distributed in Texas, Arizona, and California.
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.
Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.
Nature's Wonder Premium Soybean Sprouts are recalled due to potential Listeria monocytogenes contamination. Affected products (12 oz bags, UPC 815098001347) were distributed in seven states; discard or return if purchased.
Bean sprouts produced by Chang & Son Enterprises, Inc. are recalled due to potential Listeria monocytogenes contamination. Affected products include 10-pound bags and 12-ounce packages with sell-by dates before May 28, 2023.
SunOpta Grains and Foods Inc. is recalling Organic Pineapple Chunks due to potential Listeria monocytogenes contamination. Affected lots 8FQ229702000MX and 8FQ229802000MX were distributed in Oregon.
AH USA Group Inc is recalling Black Fungus Golden Koi 2.5 oz packages due to potential salmonella contamination. The product was distributed across 19 states.
G-SUPRESS DX pediatric drops are being recalled due to a product mix-up: an incorrect product was found inside some cartons in Puerto Rico. The recall affects 9,077 bottles (Lot D20911, expires Oct/25).
Living Nutz Nut & Seed Butter products have been recalled due to potential Salmonella contamination. The recall affects 68 units distributed across seven states.
QUADROX-i Neonatal Oxygenators may have small pinholes in packaging that compromise the sterile barrier, potentially exposing the device to non-sterile conditions and risk of infection, sepsis, or ischemia.
Linkbio Corp. is recalling 11 units of the LINK SymphoKnee System L-Shaped Femoral Augment because the packaging contains the opposite side of the implant. This error could result in implantation of the wrong component if not detected.
Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.
Akorn Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution 2% due to manufacturing deviations that prevented completion of stability studies. The product was distributed nationwide in the USA and Puerto Rico.