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.
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 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
- Affected units
- 11,808
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
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.
See all 20 products in this recall →Related recalls
Same manufacturer · KENIL HEALTHCARE PRIVATE LIMITED
See all →- ModerateNature Mint Anticavity Fluoride Toothpaste Recall CGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateMaximum Security Anticavity Gel Toothpaste recalled for CGMP deviations
FDA (Drugs) · 2025-05-28
- ModerateNature Mint Anticavity Fluoride Toothpaste Recall Due to CGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateRapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateNature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereCholecalciferol Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereCholecalciferol Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- ModerateFentanyl Citrate Injectable Solution Recall Due to cGMP Deviations
FDA (Drugs) · 2026-05-06
- SevereMethylcobalamin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23