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.
Trinity Sterile is recalling Wolf Pak Premium Dressing Change Kits labeled as latex-free. The Non-Adherent Dressing component contains natural rubber latex, creating risk for patients with latex allergies.
Wolf-Pak Premium Dressing Kits labeled latex-free are being recalled because a component contains natural rubber latex, posing a risk to people with latex allergies.
Becton Dickinson recalls 9,340 units of BD PhaSeal Y-Site Connectors (Catalog 515304) due to incorrect expiration dates printed on product labels that extend beyond the actual product expiration.
Kabobs Acquisition Inc. is recalling Tomato, Basil & Mascarpone Arancini products due to possible glass contamination from their rice supplier. Affected lot numbers include PM22F23, PM22F30, and PM22G13.
Baxter Healthcare recalls 85,680 bags of acetaminophen injection nationwide due to temperature abuse in distribution. Product was shipped in refrigerated trucks despite being labeled for room temperature storage.
Trinity Sterile's Wolf Pak Premium Dressing Change Kit is mislabeled as latex-free but contains natural rubber latex in component 94-7002. This poses a risk to people with latex allergies.
Aire-Master of America Inc is recalling Common Sense Fragrance Free Hand Sanitizer due to a manufacturing process deviation. The product was made using deionized water from a system that lacked appropriate microbial control.
Family Dollar is recalling SKYN Original, Elite, and LS non-latex condoms due to improper storage. Products sold between May 1 and June 10, 2022 were not stored in temperature-controlled conditions.
Family Dollar is recalling BIOTRU Multi-Purpose Solution (4 oz, SKU 999009) due to improper temperature-controlled storage. Approximately 1,051 units were affected across US Family Dollar stores.
Factor is recalling Tomato & Roasted Vegetable Risotto (12.6 oz) because the arborio rice ingredient contains glass. The recall affects 23,439 units.
Factor is recalling its Caramelized Onion & Goat Cheese Risotto due to glass fragments in an arborio rice ingredient. The contamination poses a choking and injury risk.
Protect U Guard Foaming Hand Sanitizer is being recalled because it was manufactured with deionized water from a system lacking proper microbial controls. The affected product was distributed in Florida, Illinois, Iowa, and New Jersey.
Nephron Sterile Compounding Center is recalling PF-Labetalol HCl Injection nationwide due to manufacturing deviations that create potential for cross-contamination. No illnesses have been reported.
Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.
Crown Prince Quality Smoked Baby Clams (3 oz cans, UPC 0 73230 00853 5) are recalled due to detectable PFAS contamination. Approximately 211,716 cans distributed nationwide are affected.
Stradis Medical recalls 850 surgical forceps (NARMD MEDICAL DEPOT Forceps, part ZZ-0701) due to potentially compromised sterile barriers. Healthcare facilities with these units should identify affected lot numbers and contact the manufacturer for guidance.
Nephron Pharmaceuticals is recalling Ketorolac Tromethamine Injection due to manufacturing deviations that could lead to cross-contamination. The recall affects 5,040 vials distributed nationwide.
Zydus Pharmaceuticals recalls Fulvestrant Injection lot B200076 due to failed purity and stability specifications. Distributed nationwide; expiration January 31, 2024.
Family Dollar's NEW SKIN Liquid Bandage was not stored in temperature-controlled conditions, potentially compromising product integrity. Affected units were sold nationwide during May through June 2022.
Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.
Minn Dak Growers recalls Fancy Buckwheat Flour due to plastic foreign material contamination. Two lot numbers were distributed in Indiana; affected consumers should discard the product.
Family Dollar is recalling Veriquick Pregnancy Test 2CT kits (SKU 903756) sold from May 1 to June 10, 2022 due to improper storage outside temperature-controlled areas.
Family Dollar is recalling Fixodent Org Cream denture adhesive (2.4oz and 0.75oz travel sizes) sold May-June 2022 due to improper storage in non-temperature-controlled areas. No illnesses reported.
Akorn, Inc. is recalling 14,712 bottles of PrednisoLONE Oral Solution (15 mg/5 mL) due to incomplete induction seals in containers. No illnesses have been reported, but the defect may affect product integrity.
Factor Shrimp & Asparagus Risotto with pesto green beans is being recalled because the arborio rice ingredient contains glass. Consumers should not consume this product.