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.
Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.
Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.
Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.
Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.
Jubilant Cadista Pharmaceuticals recalls 14,061 bottles of Prochlorperazine Maleate 5mg tablets nationwide due to subpotency. The medication failed quality testing at 18 months and contains less active ingredient than specified.
Biomerieux is recalling API NIT1 NIT2 Reagents (Catalog 70442, Batch 1009326520) distributed nationwide due to storage conditions that exceeded temperature and time parameters, preventing guaranteed product performance.
Biomerieux Inc. is recalling ETEST Clinical Imipenem IP 32 susceptibility test kits nationwide because temperature and time storage conditions were exceeded, which may affect product performance.
Randox Laboratories recalls a quality control product (PS2682) because Rheumatoid Factor concentration has declined, causing out-of-range quality control results and delayed laboratory test reporting.
Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.
Biomerieux Inc is recalling PPM Lombard R2A medium products (lot 1009527290) because storage conditions exceeded acceptable parameters, compromising product performance. Approximately 20 units distributed nationwide in the United States.
Biomerieux Inc recalls BIOBALL K.RHIZOPHILA diagnostic kits (batch 7408) due to exceeded temperature and time storage conditions that may compromise product performance.
Biomerieux Inc is recalling 187 units of VITEK 2 REAGENT AST-GN99 TEST KIT due to storage temperature and time exceedances that may compromise test performance.
Lidl US Trading is recalling Favorina Advent Calendar due to potential Salmonella contamination. Approximately 10,524 units were distributed throughout the United States.
Lukai sweetened jujube products are recalled because they contain undeclared sulfites at 17.9 mg per serving. This allergen poses a risk to consumers with sulfite sensitivity.
Hikma Pharmaceuticals recalled Ganciclovir for Injection due to a labeling error where one vial per carton was mislabeled as Cladribine Injection, creating a risk of incorrect medication administration.
Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.
Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.
NCH Life Sciences LLC is recalling hand sanitizer products containing excess acetal and acetaldehyde impurities due to manufacturing deviations. The recall affects 2.5 and 55-gallon bottles distributed nationwide in the US and Canada.
Remington Medical is recalling 290 Automatic Cutting Needles with lot number 2224920 because the stylet is longer than specified on the label. Affected units were distributed in NC, WV, CA, PA, AL, and TX.
AVKARE LLC is recalling Glycopyrrolate 1 mg tablets distributed nationwide due to failed quality specifications involving unknown impurities. The recall affects 1,237 cartons.
Phil's Power Pancakes are being recalled because they contain wheat that is not listed on the label. Consumers with wheat allergies who have purchased this product should not consume it.
TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.
Wismettac Asian Foods recalls Shirakiku Fish Sausage due to undeclared collagen (bovine dermis) casing. Approximately 4,780 units were distributed across multiple U.S. states.
Wismettac Asian Foods is recalling Premium Quality Shirakiku Fish Sausage Jalapeno because the casing contains undeclared bovine collagen. The product was distributed across 23 U.S. states.
Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution 0.5% (lot TA4844) nationwide due to failed stability specifications showing excessive weight loss that may affect medication potency.