KOFAL Topical Pain Relief Ointment Recalled for Manufacturing Practice Deviations
KOFAL, an external analgesic ointment containing methyl salicylate, is being recalled from Delaware and North Carolina markets due to manufacturing practice deviations. The voluntary recall affects approximately 11,808 jars.
What this means for you
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: This is an FDA Class II voluntary recall without reported illnesses, injuries, or deaths. The recall was initiated due to Current Good Manufacturing Practice deviations, which constitute a precautionary measure to address manufacturing compliance issues. Per the severity rubric, precautionary Class II recalls without reported harm are classified as Moderate.
Plain-English summary
KOFAL is an over-the-counter external analgesic ointment containing 10.5% methyl salicylate, used for topical pain relief. The recalled product is sold as 2-ounce (60-gram) jars. Affected units are from Lot SP30A with an expiration date of September 30, 2026, and are distributed in Delaware and North Carolina.
The recall was initiated by the manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, in response to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. CGMP deviations indicate compliance issues with FDA standards for product manufacturing, quality control, or documentation.
The recall affects approximately 11,808 jars of the product. Consumers who have purchased KOFAL from Lot SP30A should stop using it and contact their retailer or healthcare provider for guidance. The product is identified by NDC number 55758-109-02 and UPC 899711001013.
This voluntary recall was initiated by the manufacturer on April 24, 2025, and was terminated on February 19, 2026. The FDA classified this as a Class II recall.
The recalled product
- Product
- KOFAL (METHYL SALICYLATE)
- Brand
- KOFAL
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Topical Analgesic
- Hazard
- cgmp-deviation
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 SP30A
- Exp Date: 09/30/2026
UPCs (1)
- 899711001013
Distribution
Distributed in 2 states:
- DE
- NC
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