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.
Family Dollar is recalling approximately 329,044 units of Oral B Mouth Sore Rinse 237ML because the product was stored outside of labeled temperature requirements. No illnesses or injuries have been reported.
Family Dollar recalls 329,044 units of ARC Teeth Whitening Pen sold between June and October 2023 across 22 states due to improper storage outside temperature requirements.
Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.
V-Force Homeopathic bottles contain pig-derived adrenal gland instead of the labeled cow-derived ingredient. About 1,333 bottles with lot Z65842 distributed to Florida and potentially other states.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The label states a 54-month shelf life when the actual shelf life is 36 months.
Family Dollar recalls 329,044 units of GoodSense denture cleanser tablets that were stored outside their labeled temperature requirements. Products were sold between June and October 2023 at Family Dollar stores across 24 states.
Stryker Corporation is recalling Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. The devices are labeled with a 54-month shelf life but actually expire after 36 months.
Family Dollar recalled 329,044 First Response 2 CT units sold between June and October 2023 due to storage outside labeled temperature requirements. The recall affects 22 states.
Medline Industries is recalling REMEDY Antifungal powder nationwide because it contains insufficient miconazole nitrate (the active ingredient). The product was shipped before assay testing was complete.
Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect expiration date. The label states a 54-month shelf life when the actual shelf life is 36 months.
Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The product label indicates a 54-month shelf life, but the actual shelf life is 36 months.
OXAYDO oxycodone 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The affected lot is 22W02 with expiration 01/31/2025.
The Sausage Maker, Inc. is recalling Instacure #1 curing salt due to potential metal contamination. Consumers who purchased this product online should discontinue use immediately.
VistaPharm is recalling Mycophenolate Mofetil Oral Suspension because the adaptor does not fit the bottle after reconstitution. Affected lots were distributed nationwide and to Saudi Arabia.
FreshPoint Bix Produce cantaloupes are being recalled due to potential Salmonella contamination. The recalled product was distributed to Iowa, Minnesota, North Dakota, and Wisconsin.
The Kitchen Garden Co, LLC recalls Fine Sconehenge Baking Company Cranberry Orange Scones due to undeclared egg allergen. Consumers with egg allergies should not consume the product.
Asensus Surgical recalls 21 units of Senhance Surgical System due to uncontrolled laparoscope arm motion after surgeons disengage remote control. The malfunction has occurred and may recur on affected devices.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge Baking Company Chocolate Chip Scones because they contain undeclared egg allergen. The product was misbranded and poses a risk to consumers with egg allergies.
Covidien recalls 5,709 stolen McGRATH MAC video laryngoscopes that failed quality tests. These defective devices risk failed intubation and may compromise airway management.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge English Scones due to undeclared egg allergen. The scones, sold via the firm's website to customers in California and Nevada, may pose a risk to consumers with egg allergies.
Braga Fresh Foods is recalling Wegman's Organics Sweet Kale Chopped Salad Kit due to undeclared egg allergen. The product was distributed nationwide and may pose a risk to individuals with egg allergies.
Fine Sconehenge Baking Company is recalling Lemon Blueberry Scones sold through their website because they contain undeclared egg, a common allergen. Consumers with egg allergies should not consume this product.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge Lemon Raspberry Scones because they contain undeclared egg. People with egg allergies could have serious reactions.
GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) was distributed nationwide.