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.
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.
i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.
Frontier Devices 14 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 10,960 units are affected.
Frontier Devices 16 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 490 units are affected.
Top Secret Nutrition Extra Strength Uric Control, 30 veggie caps, lot C1238, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.
PrimeNutrition Phytoform Fruits & Greens Formula, 13.75 oz, lot 207460659, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 2,708 cartons are affected.
Hi-Tech Pharmaceuticals Slimaglutide, 180 tablets, lot C19El8, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.
Hi-Tech Pharmaceuticals Adderex XR, 30 tablets, lot 303120691, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Hi-Tech Pharmaceuticals L-Glutamine Ultra Pure Powder, 500 grams, lot 059960809, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
PrimeNutrition Phytoform Fruits & Greens Formula in watermelon, 13.75 oz, lot 174271126, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Frontier Devices 14 mm Distraction Pins in 5 single packs are recalled because the labeling includes a shelf life that has not been validated. 2,700 units are affected.
Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg/160 mg double strength, in 6, 10, 14 and 20-count bottles are recalled because a micro-organism was found on a lot of packaging coil.
Hi-Tech Pharmaceuticals Beta Sitosterol, 90 tablets, lot C1847, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
iForce Nutrition Joint Help dietary supplement, 120 capsules, lot 101330812, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in blisterpack cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,757 cartons are affected.
Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.
i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.
PrimeNutrition Taurine, 8.12 oz, lot 710581618, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,062 cartons are affected.
Hi-Tech Pharmaceuticals Joint-RX dietary supplement, 90 count, lot 503110607, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
PrimeNutrition Phytoform Fruits & Greens Formula in peach mango, 13.75 oz, lot 202140114, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Hi-Tech Pharmaceuticals Quercetin, 120 tablets, lot C1612, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.