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.
HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.
A batch of Trulicity (dulaglutide) injection was recalled due to temperature exposure during distribution in New Mexico. The product was exposed to temperatures outside its labeled storage requirements due to inclement weather.
Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.
Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.
Plastikon Healthcare LLC is recalling antacid suspension due to manufacturing quality control failures. The company failed to properly investigate results from microbial testing.
Driscoll's Blackberries are recalled because samples contained Formetante HCI, a pesticide not approved for use on blackberries. The affected product was distributed to 13 distribution centers across eight states.
Boston Scientific is updating instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation during use and provide best clinical practices for insertion, advancement, and removal.
R & S Roberts Enterprises recalls Milk & Dark Chocolate Sea Salt Caramels due to undeclared soy lecithin used in the releasing agent. The product may cause reactions in consumers with soy allergies.
Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.
Monarch PCM, LLC is recalling Phenobarbital Elixir USP 20 mg/5 mL because the product exceeds the USP specification for alcohol content. Approximately 15,730 bottles distributed in Tennessee are affected.
American Health Packaging is recalling Nitrofurantoin Capsules 100 mg due to dissolution failure. The drug release results were above specification. No illnesses have been reported.
Convenience kits containing Prevantics swabs used in medical procedures are being recalled because the manufacturer failed to adequately validate the manufacturing test methods used during production.
Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.
Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.
Apotex Corp. recalls Sirolimus Oral Solution lot RZ1598 for exceeding dissolution specifications at the 14-month timepoint. Approximately 2,353 bottles were distributed nationwide.
Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.
Total Resources International is recalling 891 First Aid Kits due to a potential cross-contamination issue from a manufacturing equipment breach. The kits contain electrolyte tablets that may have been exposed to pharmaceutical contaminants below therapeutic dose levels.
Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.
Bestco LLC is recalling Open Nature Cough Drops (Menthol flavor) due to insufficient menthol content. Products may not be effective as labeled.
Culinary Collective is recalling Valencian Almonds due to potential peanut contamination not declared on the label. The affected products were distributed in Colorado, Montana, New York, and Oregon.
Fagron is recalling SyrSpend SF Suspending Base, Cherry Flavored (NDC 51552-1123-5 and 51552-1123-9) due to contamination with Burkholderia gladioli. This FDA Class I recall affects medication used in compounding.
Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.
The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.
Woodside Acquisitions Inc. recalled 34,240 Oral Rapid SARS-CoV-2 Antigen Test Kits distributed in Alabama and Georgia. The tests were distributed without FDA clearance or authorization for marketing.
Ramen Hero is recalling certain lots of its Vegan Shoyu Ramen meal kits because they contain egg noodles despite egg not being listed on the label, posing a risk to people with egg allergies.