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.
Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.
Olympia Compounding Pharmacy recalled Testosterone Cypionate injection vials due to lack of sterility assurance. The affected lot was distributed nationwide. Patients should contact their healthcare provider immediately.
Olympia Compounding Pharmacy is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL injectable due to lack of sterility assurance. The affected vials were distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling Vitamin D3 injectable vials due to lack of sterility assurance. A total of 3,083 vials were distributed nationwide.
Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine HCL 100 mg/mL injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.
Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.
Devicor Medical Products is recalling 90 HydroMARK Breast Biopsy Markers due to mismatched patient labels that incorrectly identify the product model. The small patient label identifies the device as model 4010-05-08-T3, while the correct model is 4010-05-08-T4.
RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.
Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.
Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.
Olympia Compounding Pharmacy is recalling Myers Cocktail injectable vials due to lack of assurance of sterility. The recall affects approximately 13,679 vials distributed nationwide.
Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.
Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.
Higher Education Make Out Ready Vegan Lip Balm is recalled due to mislabeling of active ingredients. The label does not match the product's actual sunscreen actives.
GlaxoSmithKline is recalling 328 bottles of Tivicay (dolutegravir) tablets nationwide due to incorrect expiration date labeling. The label shows January 2027 but the correct expiration date is September 2026.
Calvin Scott & Company recalled Benzphetamine 50mg tablets due to a labeling error where bottles labeled as Benzonatate 100mg capsules contained Benzphetamine 50mg tablets and vice versa. One physician in Alpharetta, Georgia received 13 affected bottles.
Direct Rx is recalling Zonisamide Capsules USP 100 mg, lot 23JY2124, nationwide due to gaps in the quality control microbiology laboratory that could affect product verification.
Able Sales Company is recalling Tereos Wheat Gluten containing traces of 2-chloroethanol. The affected product was distributed in Puerto Rico.
Wegmans Brand Fresh Goat Cheese (Classic Chevre with Cranberries) is being recalled because pieces of cheesecloth may be present on the exterior surface. The product was distributed in New York.
Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.
Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.