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.
Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.
Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.
Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.
Charles Boggini Company is recalling Yellow Lemonade and Yellow Lemonade X (1 and 5 gallon sizes) due to undeclared FD&C Yellow No. 5. Consumers with tartrazine sensitivity should not consume the affected products.
The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in the US and internationally.
Rising Pharma's pregabalin capsules are being recalled nationwide after a pantoprazole tablet was discovered during packaging. No illnesses have been reported.
Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.
LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.
GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.
Salewa USA recalls Wild Country Ropeman 1 ascenders because the teeth can fail to engage, making it difficult or impossible to ascend. About 7,700 units sold in the United States since December 2022.
Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.
ARG Laboratories recalls Pain Wizard pain relief cream nationwide due to manufacturing defect involving propylene glycol that did not meet specifications.
ARG Laboratories is recalling 4,013 units of Aloe Gator SPF 40+ sunscreen (Lot 04023C1) distributed nationwide because the active ingredient does not meet specifications.
ARG Laboratories recalled Pain Wizard topical pain relief roll-on due to active ingredient out of specification and violative-grade propylene glycol used in manufacturing.
Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to use of a violative grade of propylene glycol during manufacturing that renders the active ingredient out of specification.
Black & Decker is recalling about 44,400 CRAFTSMAN V20 Cordless Tillers/Cultivators because misleading assembly instructions can cause consumers to attach the tines upside down, creating a laceration hazard. No injuries have been reported.
Jiangsu Shenli Medical is recalling 619,200 MEDLINE non-sterile syringes (Model 83087) manufactured in configurations outside FDA-approved specifications. The recall affects units distributed nationwide.
Jiangsu Shenli Medical Production recalled 37,200 GMAX non-sterile syringes manufactured outside FDA-approved specifications. Affected units were distributed across CA, FL, GA, IL, TN, and VA.
HP Hood is recalling Price Chopper Fat Free Cottage Cheese with Pineapple 16oz tubs due to undeclared sugar. Affected products have Item # 54267 and specific production dates in May 2024.
Sun Pharmaceutical recalls Xelpros latanoprost eye drops (Lot HAD3383A) due to particulate matter contamination detected during release testing. Affected bottles were distributed in Texas and Pennsylvania.
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection (25 mg/10 mL) in one lot due to lack of assurance of sterility. The recall affects approximately 4,136 cartons distributed in Utah.
Medline non-sterile syringes (Model 91851) are being recalled because their piston sizes and configurations exceed what the FDA approved. Approximately 7,000 units distributed in six states are affected.
Medline non-sterile 5mL syringes (model 91829) are recalled because they were manufactured outside the scope of FDA-approved specifications. About 35,000 units are affected.