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.
Joonsung Trading Inc recalls Mio Salad Dressing due to undeclared egg allergen. The label lists Mayo but fails to declare Egg, creating serious risk for egg-allergic consumers.
Benzonatate 100mg capsule bottles are mislabeled. Some contain Benzphetamine tablets instead, and vice versa. This medication mix-up affects 10 bottles distributed to one physician in Alpharetta, Georgia.
Joonsung Trading Inc recalls Champon Soup Base due to undeclared milk and tuna allergens. Affected 32 oz containers were distributed in Oregon and Washington; products dated before April 14, 2022 are recalled.
The FDA is recalling approximately 4,449 Sara Plus Active Floor Lift devices due to a fire hazard. The devices may emit smoke or ignite, posing a risk to users and staff.
Olympia Compounding Pharmacy recalls a multi-drug injectable compound (lot B41C22-22) due to inability to assure sterility. The recall affects 1,159 vials distributed nationwide.
HEB Bakery Simply Delicious Cookies with Brownie Bites Party Tray (UPC 041220488988, Lot 22063 07:08) is being recalled due to potential metal fragments in the product distributed in Texas.
Olympia Compounding Pharmacy recalls 911 vials of Ondansetron Hydrochloride (1 mg/mL) due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling 9,102 vials of Phenylephrine 1 mg/mL due to lack of assurance of sterility. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Direct Rx recalled Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels exceeding acceptable limits. The recall affects 11 bottles distributed in Florida.
Olympia Compounding Pharmacy is recalling Lipostat-Plus vials nationwide due to lack of sterility assurance. Approximately 4,843 vials were distributed across the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy recalls 2,333 vials of Sodium Selenite 200 mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA, Puerto Rico, and the U.S. Virgin Islands.
Mrs. Miller's Homemade Jam Smokey BBQ Bacon Jam is being recalled because the label does not declare soy allergen. 5,315 cases were distributed across 15 states.
Olympia Compounding Pharmacy recalled 1,710 vials of RE-2 injectable medication due to lack of assurance of sterility. Affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy is recalling 1,597 vials of Magnesium Chloride injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy is recalling SB-5, a multi-dose injectable medication, due to lack of assurance of sterility. The product was distributed nationwide; patients should contact their healthcare provider immediately.
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 vials distributed nationwide.
Olympia Compounding Pharmacy is recalling Formula F1, a compounded injectable medication, due to lack of sterility assurance. The 1,703 vials were distributed nationwide.
Olympia Compounding Pharmacy recalls 6,113 vials of Olympia Mineral Blend injectable due to lack of assurance of sterility. The product was distributed nationwide; patients should not use it and should consult their healthcare provider.
RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recall affects bottles distributed to Florida, South Carolina, and Virginia.
Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.
RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.
Olympia Compounding Pharmacy has recalled 8,664 vials of Olympia Vita-Complex B-vitamin injection nationwide due to lack of assurance of sterility. The affected multi-dose vials may pose an infection risk to patients who receive the product.
Cole's Select Curry Salmon Rice Bowl is being recalled because salmon and soy ingredients are not declared on the label. Consumers with allergies to salmon or soy should not consume this product.
Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.
Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.