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.
The Anspach Effort, Inc. is recalling five AL-III-DISS Adapters because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 462 System Console units because the supplied directions for use did not contain a recommended service interval.
Novartis Pharmaceuticals is recalling specific lots of Isopto Carpine eye drops due to failed impurities and degradation specifications.
Becton Dickinson is recalling one lot of Trypticase Soy Agar and Chocolate Agar I-Plates because they may fail to recover specific Haemophilus organisms.
McKesson Packaging Services is recalling 476 cartons of Donepezil HCl 10mg tablets because routine stability testing revealed an out-of-specification assay result.
Volkswagen Group of America is recalling 2,091 2015 Audi A3 Cabriolet vehicles because the safety certification label displays an incorrect production date.
Teleflex Medical is recalling Arrow EZ-IO Needle Sets because some individual unit pouches are missing lot numbers and expiration dates.
Valeant Pharmaceuticals is voluntarily recalling 5,647 units of CLENZIderm M.D. Acne Treatment Systems nationwide due to product discoloration.
InnovaGel is voluntarily recalling Dye Free Allergy Softgel Gelatin Capsules because they are subpotent. The affected product was distributed in New York.
Valeant Pharmaceuticals is voluntarily recalling CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment due to discoloration.
Novel Laboratories is recalling 7,656 bottles of Fluocinolone Acetonide Topical Solution 0.01% due to chemical contamination. The affected product was distributed nationwide.
Allergan is recalling 56,878 bottles of Lumigan (bimatoprost) 0.01% ophthalmic solution because the product failed impurities and degradation specifications.
Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because high levels of a degradation product were detected.
Smiths Medical is recalling CADD Administration Sets because the illustration on the Instructions for Use incorrectly depicts the filter size as 2.0 microns instead of the actual 0.2 microns.
West-Ward Columbus, Inc. is recalling Doxercalciferol Capsules 0.5mcg because capsules were found with illegible print during an internal inspection.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets due to high levels of a degradation product.
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 60 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility's inlet air duct.
G & W Laboratories is recalling 230,700 tubes of Ciclopirox Olamine Cream because some lots were packaged with an out-of-date package insert.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Dr. Reddy's is recalling Rivastigmine Tartrate Capsules because testing detected a peak for Ranitidine, indicating cross-contamination with other products.
Alvogen is recalling specific lots of Adalat CC (nifedipine) extended-release tablets due to cross-contamination with sorafenib powder.
Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.
AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.
Hetero USA Inc. is recalling 65,664 bottles of Montelukast sodium tablets due to a complaint of blue spots and powder inside a sealed bottle.