KOFAL Methyl Salicylate External Analgesic Ointment Recall
KOFAL Athletes Penetrating Pain Relief external analgesic ointment (methyl salicylate 10.5%) is being recalled due to CGMP deviations in manufacturing. The voluntary recall affects 11,808 jars distributed in Delaware and North Carolina.
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: FDA classified this as Class II. The source text indicates no reported illnesses or injuries. CGMP deviations are manufacturing/process issues rather than direct contamination or safety hazards with confirmed harm, making this a precautionary recall at the moderate level.
Plain-English summary
KOFAL, Athletes, Penetrating Pain Relief External Analgesic Ointment containing methyl salicylate 10.5% is being recalled by manufacturer Kenil Healthcare Private Limited, distributed by Pharmadel LLC. The recall affects 11,808 jars of 2 oz (60 g) jars with NDC 55758-109-02, UPC 8 99711 00101 3, Lot SP30A, expiration date 09/30/2026.
The reason for the recall is CGMP (Current Good Manufacturing Practice) deviations identified in the product's manufacture. This is a voluntary recall initiated by the firm.
The affected product was distributed in Delaware and North Carolina. Consumers in these states who have purchased this product should stop use and contact their pharmacist or healthcare provider if they have any concerns.
The recalled product
- Product
- KOFAL (METHYL SALICYLATE)
- Brand
- KOFAL
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — External 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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