Why it was recalled
CGMP Deviations
Product description
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.
Lot numbers, UPCs & expiration codes
Lost SP21A, Exp Date: 03/31/2026
Where it was sold
DE and NC
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0425-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2025
- FDA report date
- May 28, 2025
- Quantity
- 16,248 Jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
Original FDA data
Every field from FDA enforcement report D-0425-2025, exactly as published.
Show all FDA fields
- City
- Ta. Kadi, District Mehsana
- Status
- Terminated
- Country
- India
- Event ID
- 96797
- Address
- Plot 319
- Address (line 2)
- Village Acharasan, Ankhol-Vamaj Road
- Code information
- Lost SP21A, Exp Date: 03/31/2026
- Report date
- May 28, 2025
- Product type
- Drugs
- Recall number
- D-0425-2025
- Classification
- Class II
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Product quantity
- 16,248 Jars
- Termination date
- Feb 19, 2026
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- DE and NC
- Recall initiation date
- Apr 24, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 19, 2025