Class II Recall Issued for Artridon Glucosamine Over Manufacturing Concerns

A Class II recall has been issued for artridon glucosamine, a topical analgesic distributed by Pharmadel LLC and manufactured in India by Kenil Healthcare Private Limited. The product, which contains menthol 2% and methyl salicylate 15%, is marketed for arthritis joint pain relief and packaged in 5 oz (142 g) tubes. The affected lot, SP25A, with an expiration date of September 30, 2026, includes 9984 tubes distributed in Delaware and North Carolina. The recall was initiated voluntarily by the firm on April 24, 2025, and is currently ongoing.

The recall was classified as Class II by the US Food and Drug Administration (FDA) on May 19, 2025, indicating a situation in which use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The reason for the recall stems from deviations from current good manufacturing practice (CGMP) requirements, which can potentially compromise the safety, quality, or efficacy of the drug product.

Although no press release has been issued, notification of the recall was communicated via multiple channels, including email, fax, letter, and phone. Pharmacists should be aware that artridon glucosamine is intended for the topical relief of arthritis-related joint pain. It is important to verify inventory and discontinue dispensing any units from the affected lot to ensure patient safety.