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.
Daye is recalling 3,074 packs of its Trial Tampon Box because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Initiation 3 Month Heavy Flow Bundle because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Nude Regular Tampons because the product lacks 510(k) clearance.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.
Daye is recalling 3,074 packs of 18 Coated Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Initiation 36 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Heavy Flow Bundle because the product lacks 510(k) clearance.
Endo USA is recalling 2,035 cartons of Everolimus tablets 2.5 mg after results came back out of specification for impurity IP-C.
Acme United Corporation is recalling 2,338 boxes of First Aid Only Sting Relief Swabs from one lot over a product mix-up.
Daye is recalling 3,074 packs of Refill 36 Coated Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Refill 3 Month Trial Tampon Box because the product lacks 510(k) clearance.
Kenvue Brands is recalling 3,816 bottles of Extra Strength TYLENOL 500mg caplets, 24-count, from one lot because of a defective container.
Daye is recalling 3,074 packs of its Initiation 3 Month All in One Bundle because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of the Initiation 3 Month Trial Tampon Box because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Regular Flow Bundle because the product lacks 510(k) clearance.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 40 mg after an out-of-specification dissolution result at the 12-month stability station.
Daye is recalling 3,074 packs of its Initiation 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 20 mg after an out-of-specification dissolution result at the 12-month stability station.
About 6,600 Destination Holiday Glow Light Stick bracelet 12-packs are being recalled because the green bracelet can leak, posing a skin irritation hazard.
Sedecal is recalling the SHIMADZU RF.004 mobile X-ray system, serial 75723, after emailing consignees to remind users that the equipment is not water-resistant.
JB Chemicals is recalling 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg because the tablets were imprinted with the wrong identification code.
Sedecal is recalling one SM_40HF_BDC3 mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
UIH Technologies is recalling two uCT 780 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.