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 9 Coated Super Tampons and 9 Nude Super Tampons because the product lacks 510(k) clearance.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 70 mg after an out-of-specification dissolution result at the 12-month stability station.
Daye is recalling 3,074 packs of 9 Coated Regular and 9 Nude Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of 18 Coated Super Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of Refill 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.
Letco Medical is recalling 173 500 ml bottles of Espumil lipophilic foam base over a labeling issue recorded as not elsewhere classified.
Canon Medical Systems is recalling two Vantage Galan 3T MRI systems because components do not meet the required distance between electrodes for IEC 60601-1 compliance.
Endo USA is recalling 1,866 cartons of Everolimus tablets 7.5 mg after results came back out of specification for impurity IP-C.
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 9 Coated Regular Tampons and 9 Nude Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Refill 3 Month Heavy Flow Bundle because the product lacks 510(k) clearance.
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.
MicroSurgical Technology is recalling eight MST ArcDUO 9mm ophthalmic knives because springs in the accompanying suction set carry an unidentified residue that may cause eye irritation.
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.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 30 mg after an out-of-specification dissolution result at the 12-month stability station.
Greiner Bio-One is recalling 504,000 VACUETTE 2 ml coagulation tubes because the label was applied too high, shifting the printed fill level mark upward.
Daye is recalling 3,074 packs of Refill 36 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.
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 Refill 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of its Refill 3 Month All in One Bundle because the product lacks 510(k) clearance.
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 50 mg after an out-of-specification dissolution result at the 12-month stability station.
Daye is recalling 3,074 packs of Initiation 36 Coated Regular Tampons because the product lacks 510(k) clearance.
Daye is recalling 3,074 packs of 9 Coated Super and 9 Nude Super Tampons because the product lacks 510(k) clearance.