KOFAL Original recalled over manufacturing violations
- Recall date
- April 24, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- KENIL HEALTHCARE PRIVATE LIMITED recalls KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Dist…
- Recall number
- D-0425-2025
- FDA classification
- Class II
- Brand / firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Sold / distributed
- DE and NC
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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