Artridon Topical Analgesic Recalled for Manufacturing Process Deviations
Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II with no reported illnesses or injuries. The hazard is a manufacturing process deviation (CGMP violation) that presents a potential quality concern but no direct health threat is documented in the source text.
Plain-English summary
Kenil Healthcare Private Limited is recalling Artridon Glucosamine topical analgesic cream, a 5 oz (142g) tube containing menthol 2% and methyl salicylate 15% for arthritis joint pain relief. The recall includes 9,984 tubes with lot SP25A and expiration date 09/30/2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. This is a voluntary, firm-initiated recall. The product is distributed by Pharmadel LLC in New Castle, Delaware.
The recall affects units distributed in Delaware and North Carolina. Consumers who have purchased this product should stop using it and consult their healthcare provider if they have questions about alternative pain relief options.
The recalled product
- Product
- ARTRIDON (MENTHOL, METHYL SALICYLATE)
- Brand
- ARTRIDON
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Topical Analgesic
- Affected units
- 9,984
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot SP25A
- Exp Date: 09/30/2026
UPCs (1)
- 810096771513
Distribution
Part of a larger recall action
This product is one of 20 recalled by KENIL HEALTHCARE PRIVATE LIMITED under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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