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.
Alembic Pharmaceuticals is recalling 4,884 bottles of Fesoterodine Fumarate Extended-release Tablets 4 mg because Diester Impurity levels exceeded the specification limit.
ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.
ASP Global is recalling 49,000 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.
DermaRite Industries is recalling 381,619 units of PeriGuard Ointment because it was made at the same facility where other products and lots were found to be contaminated.
DermaRite Industries is recalling 57,837 units of Lantiseptic skin protectant because it was made at the same facility where other products and lots were found to be contaminated.
Quest International is recalling ReQuest Measles IgG enzyme linked immunoassay kits because the in vitro diagnostic was distributed without premarket approval or clearance.
ASP Global is recalling 1,000 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres with sodium heparin, over an inadequate quality system.
DermaRite Industries is recalling 16,006 units of PeriGiene health care antiseptic because it was made at the same facility where other products were found contaminated.
DermaRite Industries is recalling 5,876 units of McKesson Skin Protectant with lanolin because it was made at the same facility where other products were found contaminated.
ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.
ASP Global is recalling 77,500 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres untreated, over an inadequate quality system.
DermaRite Industries is recalling DermaCerin Skin Protectant Moisturizing Cream because it was made at the same facility where other products and lots were found to be contaminated.
ASP Global is recalling 209,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres untreated, over an inadequate quality system with unvalidated processes.
Golden State Medical Supply is recalling 24,869 bottles of Niacin Extended-Release Tablets USP 1,000 mg for failed dissolution specifications.
DermaRite Industries is recalling 37,272 tubes of Renew PeriProtect because it was made at the same facility where other products and lots were found to be contaminated.
DermaRite Industries is recalling 15,267 cartridges of KleenFoam Antimicrobial Foam Soap because it was made at the same facility where other products were found contaminated.
Zydus Pharmaceuticals is recalling 36,624 bottles of Bromocriptine Mesylate Capsules USP 5 mg after an out of specification result for the 2-Bromoergine impurity.
DermaRite Industries is recalling 2,673 tubes of DermaMed Ointment because it was made at the same facility where other products and lots were found to be contaminated.
ASP Global is recalling 6,050 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin, over an inadequate quality system.
ASP Global is recalling 78,000 SAFE-T-FILL micro capillary blood collection tubes, 125 microlitres with lithium heparin, over an inadequate quality system.
Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.
ASP Global is recalling 352,750 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with balanced heparin, over an inadequate quality system.
DermaRite Industries is recalling 7,736 tubes of DermaKleen antiseptic lotion soap because it was made at the same facility where other products were found contaminated.
ASP Global is recalling 27,100 SAFE-T-FILL micro collection tube extenders over an inadequate quality system with unvalidated manufacturing processes.
Exactech is recalling one Equinoxe Ergo Augments Pilot Tip Converter because it was released before design updates and performance testing were completed.