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Recall Observatory FDA recall evidence

Drug 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.

D-0627-2026

June 04, 2026

Class II

Product summary

Firm
Elevate Oral Care
Event
Event 99191
Status
Ongoing
Classification
Class II
Quantity
8132 6-packs & 2262 2-packs
Official record key
drug-enforcement:D-0627-2026

Official wording

Reason: sub potency

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.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    sub potency