More than 4,000 units of a liquid multivitamin supplement are being recalled across the United States and Puerto Rico after regulators identified the presence of “black particulate matter” in the product, raising concerns about contamination during the filling process.
The U.S. Food and Drug Administration (FDA) classified the action as a Class II recall on 19 May, having been notified of a voluntary recall initiated by the manufacturer, Llorens Pharmaceuticals International Division, Inc., in early May. A Class II classification means that consuming the affected product could cause temporary or medically reversible adverse health consequences, though the probability of serious harm is considered remote.
The recall affects Nephronex multivitamin supplement, an eight-fluid-ounce liquid formula sold in a citrus/orange flavour. The product is specifically formulated for renal patients and is marketed as a sugar-free alternative to pills and tablets, suitable for individuals with fluid restrictions. It contains a vitamin B-complex (including thiamine, riboflavin, niacin/niacinamide, vitamin B6, vitamin B12, folic acid, and pantothenic acid), vitamin C, and folic acid.
According to an alert from the California State Board of Pharmacy, the affected bottles carry the lot code “B2025” and an expiration date of “08/27.” Approximately 4,196 units are involved in the recall.
The product was sold between February 2026 and May 2026 in 24 states and territories: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Puerto Rico, Tennessee, Texas, Virginia, Washington, West Virginia, and Wisconsin.
The contamination stems from what the California Board of Pharmacy described as “the potential intermittent presence of particulate matter associated with the filling process.” The FDA’s notice refers to “black particulate matter” or a “foreign object.” Black carbon is a well-known component of particulate matter, often associated with combustion or industrial processes; its presence in an ingestible liquid indicates a failure in quality control during manufacturing, packaging, or filling. Foreign objects in such products pose a risk of gastrointestinal irritation, choking, or other temporary adverse effects, even if the likelihood of lasting harm is low.
Llorens Pharmaceuticals, based in Miami, also manufactures other prescription and over-the-counter medications, including Dologesic Df, Tusnel, Tusnel Diabetic, Conex, and Dermagesic. The company has not commented publicly on the recall.
Health officials are advising consumers who have the recalled product at home to stop using it immediately. The supplement should either be discarded or returned to the place of purchase for a refund. Anyone who experiences health concerns after taking the supplement is urged to seek medical attention. Adverse reactions can also be reported directly to the FDA’s MedWatch programme.
For further information, consumers can contact the FDA at 1-888-463-6332.