KOFAL Original Pain Relieving Ointment Recalled for CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling KOFAL Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 16,248 jars 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: FDA Class II recall with no reported illnesses or injuries stated in the source text. The hazard is a manufacturing process deviation (CGMP), a precautionary rather than acute concern, placing this in the Moderate category per the rubric.
Plain-English summary
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% topical analgesic) in 4 oz (113 g) jars. The recall involves lot SP21A with an expiration date of 03/31/2026 (NDC 55758-106-04, UPC 8 9971100128 0).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Approximately 16,248 jars were distributed in Delaware and North Carolina by Pharmadel LLC, Georgetown, DE.
Consumers who have purchased this product should stop using it and contact their healthcare provider if they have any concerns. Retailers and healthcare providers should remove the product from shelves and stop distribution. The FDA classified this as a Class II recall.
The recalled product
- Product
- KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Topical Analgesic
- Affected units
- 16,248
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)
- Lost SP21A
- Exp Date: 03/31/2026
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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