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.
LumiQuick Diagnostics is recalling Benzodiazepine Strips because they were shipped to US locations without required FDA clearances.
Smiley National is voluntarily recalling four kratom products because they contain unapproved dietary ingredients.
LumiQuick Diagnostics is recalling CK-MB Test Cards shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling MDMA/Ecstasy Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling Tramadol Test Cards because they were shipped to US locations without required FDA approvals.
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.
LumiQuick Diagnostics is recalling EDDP Test Cards because they were shipped to locations without required FDA approvals.
Fast-Pak Trading Inc. is recalling Evropa Zele Bonboni Jelly Candy in New York because laboratory analysis found the unapproved green colorant chlorophyllin.
Lupin Pharmaceuticals is recalling specific lots of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.
Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.
Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.
American Health Packaging is recalling HydrOXYzine HCl Tablets because the active pharmaceutical ingredient came from an unapproved source.
Viiv Healthcare is recalling 1,056 bottles of Tivicay (dolutegravir) 50 mg tablets because they were found to contain Promacta (eltrombopag). The recall covers products distributed nationwide, including Puerto Rico.
Stryker Howmedica Osteonics is recalling 48 Citation V40 Hip Stems because a left-sided implant was found in packaging labeled for a right-sided implant.
Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.
Tyson Foods is recalling approximately 75,320 pounds of frozen chicken nuggets that may contain small pieces of plastic. The recall affects products shipped to a retail warehouse club and institutional users in Indiana and Arkansas.
Hill Dermaceuticals is recalling 4,142 bottles of Fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Bio-Rad is recalling D-10 Hemoglobin Testing Systems because the software may occasionally generate duplicate results with incorrect sample identifiers.
Hill Dermaceuticals is recalling 13,591 bottles of Fluocinolone Acetonide 0.01% Oil Ear Drops because routine testing found the active ingredient to be subpotent.
Bonduelle USA Inc is recalling bulk totes of frozen green beans due to the presence of filth. The product was distributed in Arkansas and Iowa.
New Horizon Cuisine is recalling Chicken Demi-Glace products because they were manufactured using chicken reported to be spoiled by another government agency.
Bard Access Systems is recalling 777 PowerPort Slim Implantable Ports because the labels incorrectly state they contain silicone suture plugs, when some units do not.
Spacelabs Healthcare is voluntarily recalling G2 Clinical Access Software CDs because they contain incorrect programs, preventing customers from installing the software.
AMS Diagnostics is recalling 13 Uric Acid test kits because they were marketed outside FDA 510(k) requirements.
AMS Diagnostics is recalling 116 AMS AST kits because they were marketed outside FDA 510(k) requirements. The recall covers nationwide distribution.