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.
Baxter is updating the Instructions for Use for the SIGMA Spectrum Infusion Pump to clarify safety communication regarding cleaning practices.
Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps to update the Instructions for Use (IFU) regarding cleaning practices.
ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.
eVenus Pharmaceutical Laboratories is recalling Desflurane Liquid for Inhalation because the containers may be leaking. The recall affects 9,210 units distributed in Colorado.
Baxter Healthcare is recalling 146,224 Spectrum IQ Infusion Systems to update instructions for use regarding cleaning practices.
Mylan Pharmaceuticals is recalling specific lots of Candesartan Cilexetil and Hydrochlorothiazide tablets due to out-of-specification organic impurities found during routine stability testing.
Roche Diagnostics is recalling Albumin Gen.2 reagents due to cross-contamination causing low quality recovery and invalid calibrations.
Roche Diagnostics is recalling 180 units of Tina-quant Complement C4 reagents due to cross-contamination causing invalid calibrations.
VistaPharm is recalling Nystatin Oral Suspension because one lot failed impurity specifications. The affected product was distributed nationwide.
Devicor Medical Products Inc is recalling 49 Neoprobe GDS Control Units distributed to China because the installed software version does not match the approved version.
Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution due to high impurity levels found during stability testing.
Arbor Pharmaceuticals is voluntarily recalling Nymalize (nimodipine) oral solution because the drug is subpotent. The FDA classifies this as a Class III recall.
P & L Developments is recalling 4,752 cartons of Rite Aid 2 mg nicotine gum because the package insert is for the Canadian market and not the approved US labeling.
OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.
OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.
DNA Genotek Inc. is recalling 74 units of the PrepIT Q2A Kit because reagents were shipped after their expiration dates.
OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.
Oxford Immunotec is recalling 583 T-SPOT.TB8 test kits because they have incorrect expiration dates on the labeling.
Oxford Immunotec is recalling T-SPOT.TB50 tuberculosis test kits due to incorrect expiration dates on the test kit and substrate labels.
Exela Pharma Sciences LLC is voluntarily recalling 23,775 vials of Potassium Acetate Injection, USP due to short fill issues.
Maquet Cardiovascular is recalling Instructions for Use for the Rotaflow System Console because the documents reference an incorrect serial number.
MicroPort Orthopedics is voluntarily recalling PROFEMUR Titanium and Cobalt Chrome modular necks to replace older package inserts with the most recent revision.
OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.
OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.
The Mentholatum Company is recalling Red Cross Oral Pain Relief blister packs because the included cotton pellet box incorrectly lists Natural Eugenol Oil as an ingredient.