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.
Bluegrass Ingredients Inc. is recalling Butter Powder (50 LB bags, Product Number BDF0006, Lot 6018) due to positive Salmonella contamination. The product was distributed to Florida, Illinois, and Maryland.
Bluegrass Ingredients Inc. is recalling Butter-Rich Powder (50 LB. bags) due to potential Salmonella contamination. The product was distributed to Florida, Illinois, and Maryland.
Shaman Botanicals, LLC is recalling White Vein Advanced Alkaloids Chewable Tablets because testing found the active ingredient 7-hydroxymitragynine is present in a quantity greater than the labeled specification.
Hologic is recalling 306 units of the Aptima HPV Assay Kit (Model 303585) because the product may produce invalid or false negative test results. The affected kits were distributed to eight states and Puerto Rico.
Clover Sonoma sour cream (8 oz and 16 oz sizes) is being recalled because a broken seal on the pasteurizer may have resulted in underpasteurized product. The recall affects multiple states including California, Washington, and others.
Wawa Beverage Company is recalling Wawa Reduced Fat Milk 2% 16 oz containers because foreign plastic material was discovered on the fill line during production.
Wawa Beverage Company is recalling Wawa Chocolate Low-fat Milk 16 oz bottles because foreign plastic material was discovered on the fill line during production.
Saputo Cheese USA is recalling Great Value Lowfat Cottage Cheese due to potential under-pasteurization caused by a broken pasteurizer seal. The product was distributed to ten states.
Dreamland Inc is recalling Zaatar Chickpea Salad distributed to Haggen stores in Washington because it contains undeclared sesame, soy, and wheat allergens not listed on the label.
The Welch Allyn Spot Vision Screener VS100 may display flickering due to a software issue. Flickering light exposure could trigger photosensitive seizures in susceptible individuals.
Centricity Universal Viewer versions 7.0 through 7.0 Sp2.0.1 contains a cybersecurity vulnerability that may expose login credentials on workstations, potentially allowing unauthorized access to medical imaging systems.
ConvaTec is recalling the EsteemBody Drainable Pouch due to a manufacturing defect that may cause the pouch to leak. The affected product has been distributed worldwide.
Diagnostica Stago's STA Liatest D-Di diagnostic kits are recalled due to a positive bias in D-dimer measurements throughout the analytical range. This affects the accuracy of test results used in clinical diagnosis.
Centricity Universal Viewer Software versions 6.0 through 6.0 Sp10.4.1 contain a cybersecurity vulnerability that could expose user login credentials on affected workstations, potentially allowing unauthorized access to medical imaging data and systems.
ConvaTec is recalling EsteemBody Drainable Pouch (10-35mm, Lot 5K01728) because a manufacturing issue may cause the pouch to leak. No illnesses or injuries have been reported.
Abbott is recalling ID NOW Influenza A & B 2 diagnostic tests nationwide due to higher-than-expected rates of invalid results in one lot. Affected persons should consult their healthcare provider about their test results.
ASUKAR FOODS CORP is recalling TETAS Mireya Cherry Milkshake (Colita con Leche) popsicles because they contain undeclared soy lecithin, which may cause serious reactions in consumers with soy allergies.
Clover Sonoma low-fat cottage cheese (16 oz and 32 oz sizes) is being recalled due to potential under-pasteurization from a broken pasteurizer seal. The product may not be safe for consumption.
Frito-Lay North America is recalling Miss Vickies Spicy Dill Pickle 8 oz bags that contain undeclared milk allergen. Affected products were distributed in Arkansas, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.
Dr. Praeger's Sensible Foods Inc. is recalling Simply Nature Spinach Bites (12 oz) due to the possibility of rodent hair contamination. The affected product was distributed to Maryland and Pennsylvania.
Apotex Corp. is recalling brimonidine tartrate/timolol maleate ophthalmic solution nationwide due to lack of sterility assurance. The recall affects 107,136 vials across two lots.
Strides Pharma is recalling Children's Ibuprofen Oral Suspension due to the presence of gel-like masses and black particles found in the product. Affected lots 7261973A and 7261974A should not be used.
Somerset Therapeutics LLC recalled 62,190 vials of Dexamethasone Sodium Phosphate Injection due to out-of-specification impurities detected during stability testing. The affected lot was found to contain elevated levels of certain degradation products at product expiry.
Howmedica Osteonics' MICS3 Angled Sagittal Saw Attachment screws may loosen and detach during use. The recall affects approximately 1,098 units distributed nationwide and internationally.
Elekta recalls Leksell Gamma Knife radiosurgery systems where the adapter may not be properly aligned or locked in place, potentially affecting treatment delivery accuracy.