Why it was recalled
sub potency
Product description
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
Lot numbers, UPCs & expiration codes
Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026.
Where it was sold
Nationwide
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-0627-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 4, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- 8132 6-packs & 2262 2-packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Elevate Oral Care
Original FDA data
Every field from FDA enforcement report D-0627-2026, exactly as published.
Show all FDA fields
- City
- West Palm Beach
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99191
- Address
- 346 Pike Rd Ste 5
- Address (line 2)
- Suite 1, 5, 13, & 23
- Code information
- Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026.
- Postal code
- 33411-3819
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0627-2026
- Classification
- Class II
- Recalling firm
- Elevate Oral Care
- Product quantity
- 8132 6-packs & 2262 2-packs
- Reason for recall
- sub potency
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 4, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2026