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.
Terex Utilities is recalling Power Over Fiber Base Modules because the devices lack proper laser certification and contain incorrect safety labeling regarding their laser class.
Windstone Medical Packaging is recalling 60 AMS Angio Pack-RX convenience kits (lots 230658, 231173) because the included Elevaris Lidocaine HCl injection was recalled by its manufacturer due to supplier quality issues.
Windstone Medical Packaging is recalling 24 AMS Heart Cath Tray convenience kits containing Elevaris Lidocaine HCl injection because the lidocaine was recalled for supplier quality issues.
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging is recalling 3,378 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP because the lidocaine was recalled due to supplier quality issues.
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Glenmark Pharmaceuticals is recalling azelaic acid gel 15% after receiving complaints that the product felt grainy, gritty, or sandy. The nationwide recall covers specific lots with expiration dates from February through April 2028.
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (75 mg) because testing showed impurities exceeded established limits during stability testing.
Ascend Laboratories is recalling dabigatran etexilate capsules due to an out-of-specification result in related substance testing involving Impurity II, Impurity III, and total impurities observed during 12-month stability testing.
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (150 mg) because testing showed impurities exceeded established limits during stability testing.
Medline Industries, LP is recalling specific C-Section convenience kits because they contain Bupivacaine Hydrochloride in Dextrose Injection, USP, which is subject to a voluntary recall due to quality issues.
JB Chemicals and Pharmaceuticals Ltd is recalling 34,020 bottles of Cetirizine Hydrochloride Tablets USP 5 mg because some tablets were found to contain Ranitidine due to cross contamination.
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO Cooling Eye Drops due to a lack of assurance of sterility. The recall affects multiple lots distributed nationwide within the United States.
Medline Industries, LP is recalling specific Medline kits containing B. Braun convenience kits because they include Bupivacaine Hydrochloride in Dextrose Injection, USP, which has been recalled due to quality issues.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 50 mcg, due to subpotency. The recall affects nationwide distribution in the USA and involves specific lot numbers.
The FDA is recalling ROHTO OPTIC GLOW sterile eye drops due to a lack of assurance of sterility. The recall affects 1,278,457 cartons distributed nationwide in the U.S.
Boston Scientific is recalling FARADRIVE STEERABLE SHEATH (CLEAR) because improper dilator insertion can damage the hemostatic valve, potentially leading to air ingress and air embolism.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 25 mcg, lot N02212, due to subpotency. The recall is nationwide and voluntary.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 25 mcg, due to subpotency. The recall affects nationwide U.S. distribution of specific lot numbers.
Green Jeeva LLC is recalling Organic Moringa Powder (Product code: GJ96) because it may be contaminated with Salmonella.
Medline Industries is recalling 318 medical procedure kits that contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection due to quality issues that could result in drug ineffectiveness.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 150 mcg, lot N02167, due to subpotent drug concerns. The recall affects nationwide distribution in the USA.
Rohto Digi-Eye cooling eye drops are recalled due to a lack of assurance of sterility. The recall affects 65,219 cartons distributed nationwide in the U.S.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 88 mcg, lot N02310, due to subpotency. The recall is voluntary and affects nationwide distribution in the USA.
GELLERT GLOBAL GROUP is recalling Fusia Asian Inspirations Kimchi & Tofu Kimbap because it contains undeclared fish.