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 14,808 bottles of Bromocriptine Mesylate 5 mg capsules because stability samples failed impurity tests.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits to emphasize that PSA values must be interpreted according to current clinical guidelines for biochemical recurrence.
Pharmavite is recalling specific lots of Nature Made adult gummies Hair.Skin.Nails because they may exceed specifications for total viable plate count.
Sorin Group USA is recalling Aortic Arch Cannulas because the tip angle is less than the required 45 or 90 degrees.
Mentor Texas, LP. is recalling 65 units of MENTOR CPX4 breast tissue expanders because a 350cc unit was found in a carton intended for 450cc units.
Inland Seafood, Inc. is recalling Spinach Krab & Artichoke Dip sold at Whole Foods Market due to possible contamination with wood pieces.
Amerisource Health Services is recalling 221 cartons of mixed amphetamine tablets due to unit dose mispackaging, where blister cavities may contain more than one tablet.
Teva North America is voluntarily recalling 1,299 bags of Argatroban Injection due to Current Good Manufacturing Practice (CGMP) deviations.
Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.
Mentor Texas, LP. is recalling 70 units of CPX4 breast tissue expanders because a 350cc product was found in a carton labeled for the 450cc version.
Ecolab is recalling specific Microtek angiography drapes because their sterile packaging may contain small holes in the film, potentially compromising sterility.
Ricker Hill Orchards is recalling Cran-Breeze juice because it contains patulin levels above the FDA limit of 50 ppb.
Inland Seafood, Inc. is recalling Inland Market Premium Blue Crab Spread due to possible contamination with wood pieces.
Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.
Inland Seafood is recalling Reduced Fat Seafood Cheese Spread sold at Publix due to possible contamination with wood pieces.
Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.
Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.
Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.
Inland Seafood, Inc. is recalling Alaskan Salmon Salad sold at Whole Foods Market due to possible contamination with wood pieces.
Inland Seafood, Inc. is recalling Inland Market Maryland Crab Cake due to possible contamination with wood pieces.
Zimmer Biomet is recalling a specific lot of Coonrad/Morrey Elbow Pin/Bushing Replacement Kits because they are missing a humeral bushing, which could delay surgery.
Novadaq is recalling 20 units of SK6000 PAQ sterile drape pouches because pinholes were found in the film material during shipping validation testing.
Aspen Surgical Puerto Rico Corp. is recalling 6,000 stainless steel surgical blades that were incorrectly labeled as size 12 instead of 12B.
Anthogyr is recalling 10 units of Axiom 2.8 dental implants because an FDA inspection revealed the firm failed to validate the design and process of the devices.
Anthogyr is recalling 111 units of Axiom REG dental implants because an FDA inspection found the firm failed to validate the design and process of the devices.