Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Cell Marque is recalling Her2/Neu (c-erbB-2) reagents because they were not labeled as 'For Export Only' as required by law.
Tosoh Bioscience is recalling 64 boxes of AIA-PACK TgAb Control Set because the labels included instructions for a non-FDA approved methodology.
Cell Marque is recalling five units of H. pylori reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Acumedia Manufacturers, Inc. is recalling 16 units of Beef Extract Powder (PN 7228) because the label displays an incorrect expiration date.
Sandoz Inc is recalling 4,464 bottles of Amoxicillin and Clavulanate Potassium tablets found to be subpotent in clavulanic acid.
Cell Marque is recalling Varicella Zoster Virus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling 8 units of Estrogen Receptor reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling Her2/Neu (EP3) reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Cell Marque is recalling three units of SV40 (MRQ-4) reagent because they were not labeled 'For Export Only' as required by law.
Tosoh Bioscience is recalling 15 boxes of AIA-PACK TPOAb Control Sets because the labels included instructions for a non-FDA approved methodology.
Cell Marque is recalling specific lots of Herpes Simplex Virus II reagents because they were not properly labeled as 'For Export Only' as required by federal law.
Cell Marque is recalling Herpes Simplex Virus I reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
RB Manufacturing is recalling Schiff Move Free Advanced Plus MSM & Vitamin D3 tablets due to incorrect packaging.
Medtest Holdings is recalling Pointe Scientific Chemistry Controls Level I and II because the original mean assigned to the controls was too high, resulting in a new assigned mean outside the published range.
Qualitest Pharmaceuticals is recalling 109,620 bottles of Hydrocortisone Lotion, USP, 2.5% because the product is superpotent, meaning it contains more active ingredient than specified.
Strides Pharma Inc. is recalling Benzonatate capsules due to out-of-specification preservative levels. The FDA classified this as a Class III recall.
Volkswagen is recalling 2017 Jetta vehicles because the VIN on the body does not match the VIN plate near the windshield, violating federal certification regulations.
Sun Pharmaceutical Industries is recalling 13,200 bottles of Children's Cetirizine Hydrochloride Chewable Tablets due to out-of-specification tablet hardness.
Teligent, Inc. is voluntarily recalling 3,600 tubes of Desoximetasone Ointment 0.25% in Tennessee due to a superpotent drug classification.
Medtest Holdings is recalling Pointe Scientific Hitachi AST Reagent because the package insert contains inconsistent linearity values in different sections.
Abbott Medical Optics is recalling 360 AMO Vitrectomy Cutters because 20GA and 25GA models may be packaged in the wrong sizes.
BMW is recalling 2017 X5 M and X6 M vehicles because the tire information label lists the wrong tire size, failing to meet federal safety standards.
Mentor Texas, LP. is recalling 28 units of Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implants because the Dome Pack accessory is missing.
Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 bottles distributed nationwide and in Puerto Rico.
Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.