Recent Food and Drug Administration regulations affecting small businesses

French Broad Chocolates PBC recalls Bette's Bake Sale Bonbons in 6pc, 12pc, and 24pc boxes (batch numbers 260414 and 260417) due to undeclared walnuts that pose allergy risks.

The FDA issues a final 10-year debarment order against Kimberly Schaff Kiehl, prohibiting her from importing or offering for import any drug into the United States based on felony convictions related to drug importation.

FDA adds constituents to the established list of harmful and potentially harmful substances in tobacco products and tobacco smoke under the Federal Food, Drug, and Cosmetic Act.

The FDA amends its Commissioner's National Priority Voucher Pilot Program public hearing notice to reflect changes in meeting dates, addresses, and contact information; original hearing was announced March 23, 2026.

FDA classifies digital therapy devices for amblyopia as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burdens for this ophthalmic category.

B Braun Medical recalls 328,640 hemodialysis bloodline units (SL-2000M2095L and related models) distributed nationwide and in Canada due to potential air bubble accumulation that may cause serious injury or death.

Arjo Tenor mobile passive patient lift models KHA1000 US and KHA1010 US are subject to a Class II recall affecting 119 units nationwide due to actuator components that may fail suddenly, causing uncontrolled descent of the lifting arm.

FDA classifies Alzheimer's disease pathology assessment tests as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

Siemens Medical Solutions recalls 73 ARTIS Pheno VE30A and VE40A imaging systems due to brightness variation during 3D acquisitions that may cause unintended low-dose radiation exposure to patients.

Insulet Corporation recalls Omnipod 5 Pods from 49 lots (Model PT-001662) due to manufacturing defects causing internal cannula tears that result in insulin leakage and under-delivery, posing serious health risks.

Philips Spectral CT on Rails (Model 728334) is subject to a Class II recall due to three software issues affecting gantry positioning, display messaging, and brain scan planning functionality.

FDA classifies mandibular-movement-based sleep apnea testing devices as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

Remel Inc. issued a Class II recall for Yeastone Broth (2,819 units distributed worldwide) due to potential incorrect AST results during quality control that may delay antifungal treatment responses.

Island Kinetics CoValence Laboratories recalls 28,163 bottles of Blemish Spot Treatment nationwide due to failed stability specifications that may cause temporary or reversible health problems.

Medline Industries recalls 640 CENTURION Circumcision Kits (SKU CIT7050F) distributed in South Carolina due to lack of required sterilization process, posing temporary health risks.