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.
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
Waldemar Link GmbH & Co. KG is recalling 21 units of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment components because they may not meet manufacturing specifications. No injuries have been reported.
Springworks Organic single cut green leaf lettuce may contain metal shavings dust. The FDA Class II recall affects 224 cases distributed to Connecticut, Maine, and New York.
Sun Pharmaceutical recalled Amphotericin B Liposome for Injection due to subpotent drug content. The recall involved 12,960 vials distributed nationwide across the United States.
Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.
RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.
Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.
Homeocare Laboratories recalls Kanjo Homeopathic Pain Relief Cream due to manufacturing process deviations. The recall affects 921 bottles distributed nationwide.
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
Bebelyn Colic Drops homeopathic remedy is recalled due to Current Good Manufacturing Practice deviations. Approximately 5,956 bottles were distributed nationwide.
Anatox Inc has recalled Sonne's Detoxificant #7 due to elevated lead levels. The voluntary recall affects approximately 2,870 bottles distributed in multiple states.
Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.
StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.
StellaLife VEGA Oral Care Spray is being recalled for manufacturing deviations. The product was distributed nationwide; consumers should discontinue use of affected lots.
StellaLife VEGA Oral Care Gel is being recalled nationwide due to manufacturing practice deviations. Approximately 38,105 tubes are affected by this voluntary recall.
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets 50 mg nationwide due to inadequately sealed blister packaging. Affected lot M04343 (expiration 04/2024) may have compromised product integrity.
Anatox Inc is recalling VIT-RA-TOX Calphonite #38 and Sonne's Calphonite #2 due to elevated lead levels. A total of 6,777 bottles distributed across 27 states are affected.
The FDA is recalling StellaLife VEGA Oral Care Rinse nationwide due to current Good Manufacturing Practice (cGMP) deviations. The manufacturer voluntarily initiated the recall.
Great Lakes Coca-Cola Distribution LLC is recalling Fanta Orange 12-pack cases distributed in California because packages labeled zero sugar actually contain full sugar. Consumers relying on accurate labeling for dietary reasons should not consume affected products.
Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.
Homeocare Laboratories is recalling Arnica 7 Cream due to manufacturing standards deviations. The recall affects 2,376 bottles with lot number 2446.
SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.
Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.
Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.
DoloEar Earache Drops are being recalled due to manufacturing practice deviations. Homeocare Laboratories voluntarily initiated the recall, which was terminated in September 2024.