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 Initiation 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.
Endo USA is recalling 6,655 cartons of Everolimus tablets 5 mg after results came back out of specification for impurity IP-C.
Daye is recalling 3,074 packs of its Trial Tampon Box because the product lacks 510(k) clearance.
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 Initiation 36 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Initiation 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.
Endo USA is recalling 935 cartons of Everolimus tablets 10 mg after results came back out of specification for impurity IP-C.
Daye is recalling 3,074 packs of its Refill 3 Month All in One Bundle because the product lacks 510(k) clearance.
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 its Refill 3 Month Trial Tampon Box because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of 9 Coated Regular Tampons and 9 Nude Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of 9 Coated Regular and 9 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Nude Regular Tampons 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 its Heavy 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.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 10 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.
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg across several lots after routine stability testing returned an out-of-specification result for highest unknown impurity.
Synthes is recalling 120 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.
Sedecal is recalling 39 SM-40HF-B-D-C 40KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 268 model 40KWFXPLUS mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Lannett is recalling 46,848 bottles of Niacin Extended-release Tablets USP 1,000 mg across several lots for failed dissolution specifications.
Sedecal is recalling nine SM-40HF-Batt 40KW analog mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling seven model 40KWFXPLUS-710CW.007 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.