D-0627-2026 Class II Ongoing
FDA drug recall D-0627-2026 was initiated by Elevate Oral Care on June 4, 2026 and is designated Class II. Reason for recall: sub potency The recall status is ongoing. Affected quantity: 8132 6-packs & 2262 2-packs.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2026
- Initiation Date
- June 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8132 6-packs & 2262 2-packs
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.
Reason for Recall
sub potency
Distribution Pattern
Nationwide
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.