Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Stryker is recalling the HoloBlueprint Application (Catalog Number MRUE001) for Total Shoulder Arthroplasty due to software and instrumentation malfunctions that prevent the system from meeting its intended use.
Glenmark Pharmaceuticals is recalling Lacosamide Tablets 200mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects specific lot numbers with expiration dates ranging from April 2025 to April 2026.
Asegua Therapeutics is recalling 18,541 cartons of Sofosbuvir and Velpatasvir tablets nationwide due to defective blister packs that are not properly sealed, resulting in loose tablets in cartons. No illnesses or injuries have been reported.
Glenmark Pharmaceuticals is recalling Saxagliptin 2.5mg tablets nationwide due to manufacturing quality issues. The firm initiated this voluntary recall on March 13, 2025.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets, 10mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects one lot distributed nationwide.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fenofibrate Capsules 67 mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 100-count bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg (Lot #17230819) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and initiated by the manufacturer.
Glenmark Pharmaceuticals Inc., USA is recalling Frovatriptan Succinate 2.5mg tablets nationwide due to current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this as a Class II recall.
Glenmark Pharmaceuticals is voluntarily recalling Cetirizine HCL 10mg tablets distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice deviations.
B. Braun Medical Inc. is recalling a sodium chloride irrigation solution due to the presence of particulate matter. The product was distributed to 12 distributors who may have further distributed it nationwide.
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets due to a manufacturing quality deviation involving an impurity above recommended limits.
Imprimis NJOF is recalling 2,822 bottles of sterile ophthalmic solution because stability testing showed subpotent drug strength below specifications.
Ethicon Endo Surgery recalls PDS PLUS VIO surgical sutures with needles due to silicone curing defects during manufacturing. 792 units were distributed worldwide.
Tolterodine Tartrate Extended-Release Capsules, 2 mg (Lot T05393) are being recalled because they failed dissolution specifications. The capsules may not dissolve as intended.
Alliance RV is recalling certain 2025 Avenue 23ML travel trailers because the Federal Placard may show incorrect unloaded vehicle weight and cargo carrying capacity.
Amerisource Health Services is recalling Voriconazole 50 mg tablets distributed nationwide due to current Good Manufacturing Practice deviations related to repackaging.
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D reagent (1,699 units) due to an incorrect International Sensitivity Index (ISI) value printed on the box. No illnesses or injuries have been reported.
Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.
Veridance Pharmacal is recalling 450 bottles of Omni-Macs McDonagh Medical Center Dietary Supplement because iodine levels exceed what is claimed on the label. One customer in Gladstone, Missouri received the affected product.
Paletas Ice Cream is recalling Flor de Michoacan Blue Hawaiian Beverage Concentrate because the product contains undeclared Red #3 dye. Affected products were distributed in Arizona, New Mexico, Texas, and Utah.
U.S. Trading Company recalled dried lily flowers due to undeclared sulfites, which pose a risk to people with sulfite sensitivity. The recall affected 5,200 packages distributed across 32 states and was terminated July 1, 2025.
Consumer Product Partners is recalling Hydrogen Peroxide Topical Solution bottles with incorrect back labels indicating 91% Isopropyl Alcohol. The labeling mixup affects 25,932 bottles distributed in Virginia.
Our Family Traverse City Cherry Ground Coffee (12 oz) has been recalled due to mislabeling. A portion of production was labeled as decaffeinated when it contains regular caffeine.
Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.
Baxter Healthcare is recalling the Mobile column TruSystem 7500 due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled. Approximately 1,596 units distributed nationwide are affected.