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.
Dr. Reddy's Laboratories is recalling ZENATANE (isotretinoin) 20 mg capsules because they failed to meet dissolution specifications. The recall covers 3,858 prescription packs distributed nationwide.
Circulatory Technology Inc is recalling 958 units of Better-Bladder devices with 14-inch tubing due to twisted or wrinkled balloon components.
Teva Pharmaceuticals USA is recalling MitoXANTRONE Injection USP vials nationwide because they may fail to meet specifications for Impurity D throughout their shelf life.
Amerisource Health Services is recalling 648 cartons of Paricalcitol Capsules, 1 mcg, due to failed impurities specifications.
Arthrex, Inc. is recalling 45 Suture Washers because the suture and washer were not assembled and were placed loose in the package.
Terumo is recalling CDI H/S Cuvettes because they may fail to connect to the probe, causing the monitor to display an error and preventing blood parameter display.
Siemens Healthcare Diagnostics is recalling RAPIDPoint 405 Measurement Cartridges due to an error in the value assignment for Chloride calibrators.
Siemens is recalling RAPIDPoint 400 Measurement Cartridges because of an error in the value assignment for Chloride calibrators.
The Coca-Cola Company is recalling specific lots of Dr Pepper and Diet Dr Pepper cans where the opening tab may pop upward instead of downward.
Biocompatibles is recalling Varithena administration packs because they contain the incorrect type of syringe. The recall covers 3,254 packs distributed nationwide.
Shire is recalling 7,680 bottles of Vyvanse 30 mg capsules because foreign tablets or capsules were found in the product.
Unichem Pharmaceuticals is recalling 368 bottles of Lamotrigine 150 mg tablets because they have the wrong imprint. The FDA classifies this as Class III.
Pfizer is recalling 1,316 bottles of Premarin 1.25 mg tablets because they were labeled with an incorrect expiration date of 11/17 instead of 09/17.
Mckesson Packaging Services is recalling 3,492 cartons of Xanax (Alprazolam) 0.5 mg tablets because the primary blister card labels are blank and lack product information.
CooperSurgical, Inc. is recalling 4 units of Sage CSC Thawing Medium because the products contain an international package insert instead of the correct USA package insert.
Genzyme is recalling 9,530 vials of Mozobil (plerixafor) because some have incorrect or missing lot and expiration dates.
Lupin Pharmaceuticals is recalling 20,556 bottles of Lisinopril 30 mg tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Shearer's Snacks is recalling Keebler Sugar Wafers, Strawberry, because the refined granulated sugar ingredient contained extraneous foreign matter.
Lupin Limited is recalling 3,192 bottles of Escitalopram Tablets USP 20 mg because the labels may have incorrect or missing lot and expiration dates.
Shearer's Snacks is recalling Family Gourmet Sugar Wafers because an ingredient contained foreign matter. The product was distributed to Family Dollar locations in ten states.
CooperSurgical is recalling Sage CSC Freezing Medium because it shipped with an international package insert instead of the correct USA version.
Biomet 3i is recalling 92 units of 3I Osseotite dental implants because they were incorrectly packaged. The affected units were distributed in the US and several international countries.
West-Ward Pharmaceuticals is recalling specific lots of Amoxicillin For Oral Suspension because the bottles are missing the colored panel that displays the product strength.
Shearer's Snacks is recalling Family Gourmet Sugar Wafers because an ingredient contained foreign matter. The product was distributed to specific states.
Arcobasso Foods is recalling 240,000 bottles of Panera Bread Balsamic Vinaigrette Dressing due to consumer complaints of bulging bottles.