June 2026 FDA Recall Povi-one by Elevate Oral Care
D-0627-2026 - sub potency
This Class II drug recall was voluntarily initiated by Elevate Oral Care on June 4, 2026 for the product Povi-one. The FDA reported the reason for recall as sub potency. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0627-2026
sub potency
06-04-2026
07-01-2026
8132 6-packs & 2262 2-packs
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Elevate Oral Care
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# 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.
