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.
Microbiologics Inc recalls KWIK-STIK IVD control product (lot 323-108-7) containing 47 packs due to pouches being labeled with incorrect catalog number 726-57-10 instead of correct labeling.
General Motors is recalling certain 2022 Cadillac XT6 vehicles because the brake fluid reservoir cap may be missing its required warning label. Without the label, brake fluid could become contaminated with debris, affecting brake performance.
Edge Pharma, LLC is recalling Dexamethasone sodium phosphate 0.4% topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in 56 cartons.
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 418 jars of the topical oral anesthetic product distributed across multiple lot codes.
Edge Pharma is recalling Mitomycin-C sterile ophthalmic solution syringes because the manufacturer lacks assurance of sterility. The recall affects 154 syringes distributed nationwide.
Mylan Pharmaceuticals Inc is voluntarily recalling Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol due to current Good Manufacturing Practice (cGMP) deficiencies. The recall affects 233,199 10-gram aerosol containers distributed nationwide.
Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.
GE Vscan Extend portable ultrasound devices may not power on due to battery depletion caused by improper device handling. The device must be properly turned off before removing the battery or disconnecting from power sources.
Edge Pharma, LLC is recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution (4%/1%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 231 bottles.
Edge Pharma is recalling 1,173 jars of BLT Topical Cream (Benzocaine/Lidocaine/Tetracaine) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, firm-initiated Class II recall.
Edge Pharma, LLC is recalling Tetracaine HCl Nasal Solution, 4%, due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 114 bottles distributed nationwide.
GE Healthcare is recalling the Vscan Extend portable ultrasound device due to battery power failure. The device may not power on when the battery is depleted, particularly if not turned off before battery removal or when connected to a computer without AC power.
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 175 jars of the topical oral anesthetic gel.
GE Healthcare is recalling Vscan Extend portable ultrasound devices that may fail to power on due to battery depletion when the device is not turned off before battery removal or before connecting without AC power.
Edge Pharma is voluntarily recalling 353 jars of Profound Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process.
Dental Alliance Holdings LLC is recalling CariFree CTx4 Gel 5000 fluoride gel tubes because they contain less sodium fluoride than stated on the label. The affected product is CTx12 5000 Kit lot 142017.
Edge Pharma, LLC is recalling 20 vials of Dibutyl Squaric Acid topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The drug was distributed in multiple dose vials containing 1%, 10 mL each.
GE Healthcare is recalling GE Vscan Extend portable ultrasound devices that may fail to power on if not turned off before battery removal or when connected to a computer without AC power.
Edge Pharma is recalling 757 syringes of Vitamin K Oral Solution nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall was initiated voluntarily by the firm and has been terminated.
Edge Pharma, LLC is recalling 1055 bottles of CSF Otic Insufflation Capsule containing Sulfacetamide Sodium, Ciprofloxacin, and Amphotericin B nationwide due to CGMP manufacturing deviations.
FlexDex Inc. is reinforcing instructions for the 8mm FlexDex Needle Driver (Product Code FD-335 ND). Users should not use the product if packaging shows any damage, including pinholes or tears.
Edge Pharma, LLC is recalling 63 vials of Dibutyl Squaric Acid Topical Solution (2%, 10 mL per vial) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Edge Pharma, LLC is recalling 2,204 vials of Cantharidin PLUS, a topical gel-forming suspension used to treat skin conditions. The recall is due to manufacturing quality control deviations discovered during production.
Dental Alliance Holdings LLC is recalling the CTx21 Kit because the product contains less sodium fluoride than stated on the label. Affected lots were distributed nationwide.
Edge Pharma, LLC is recalling Promethazine HCl Topical Ointment, 2.5% due to CGMP (Current Good Manufacturing Practice) deviations. The voluntary nationwide recall affects approximately 7,788 syringes distributed across multiple lots.