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.
McKesson is recalling doxycycline hyclate 100 mg tablets nationwide due to temperature abuse during manufacturing that fails to meet good manufacturing practice standards.
Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.
McKesson Medical-Surgical is recalling Diphenhydramine HCl oral solution nationwide due to temperature abuse during manufacturing. No illnesses or injuries have been reported.
McKesson Medical-Surgical is recalling Dihydroergotamine Mesylate Injection (NDC 0574-0850-10) due to temperature deviations during manufacturing that may affect product quality. The drug was distributed nationwide.
Zydot Ultimate Blend The Original Detox Drink is recalled for undeclared preservatives (potassium sorbate, sodium benzoate) and food coloring R40. The recall involves 1,150 bottles distributed in the USA.
McKesson Medical-Surgical is recalling Polymyxin B and Trimethoprim Ophthalmic Solution nationwide due to temperature deviations during manufacturing. The medication may not work as intended.
McKesson Medical-Surgical is recalling Betamethasone Dipropionate Cream USP 0.05% due to temperature-abuse cGMP deviations. The FDA Class II recall affects nationwide distribution.
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.
McKesson Medical-Surgical is recalling Tetracaine Hydrochloride Ophthalmic Solution due to cGMP deviations from temperature abuse. The recall affects 43 cartons distributed nationwide.
GRUVIPA S.L. is recalling CB1102006 BOCATA 120 sandwiches distributed in Florida due to potential insect filth contamination of the finished product.
Proventil HFA inhalers are being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during manufacturing, a deviation from FDA Good Manufacturing Practice standards.
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection vials (NDC 55150-0170-30) distributed nationwide due to temperature abuse during manufacturing that may affect product quality. No illnesses have been reported.
Zydot Unlimited recalls 1,150 bottles of Zydot Ultimate Blend detox drink due to undeclared preservatives and food colorants on the label.
McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.
McKesson Medical-Surgical is recalling Lidocaine and Prilocaine Cream due to cGMP deviations involving temperature abuse during distribution. The recall affects 23 tubes distributed nationwide.
McKesson Medical-Surgical is recalling Lidocaine Patch 5% nationwide due to temperature abuse during distribution that may have compromised product quality. The FDA classified this as a Class II recall.
McKesson Medical-Surgical is recalling Teva Propofol Injectable Emulsion (200 mg/20 mL, 25-vial cartons) nationwide due to temperature abuse during manufacturing that may affect product quality. A total of 564 cartons were distributed.
Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.
McKesson Medical-Surgical is recalling Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.
The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.
McKesson Medical-Surgical is recalling Triamcinolone Acetonide cream nationwide due to cGMP deviations related to temperature abuse during manufacturing. Specific lot numbers of affected product could not be identified.
McKesson is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide due to temperature deviations during storage that may affect medication stability.
McKesson Medical-Surgical is recalling Ketoconazole Cream 2% (60-gram tubes) distributed nationwide due to cGMP deviations involving temperature abuse during manufacturing.
BSN Medical Inc is recalling JOBST Compri2 and Compri2 lite compression bandages because the folding boxes containing the products are mislabeled. The actual products and immediate packaging are correctly labeled.
McKesson Medical-Surgical Inc. recalls E-Z-GAS II antacid product distributed nationwide due to cGMP deviations resulting from temperature abuse during manufacturing.