The Recall Desk
ModerateFDA (Drugs)·D-0759-2021·Announced 2021-09-01

PDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient

Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a subpotent drug product. No illnesses or injuries are reported in the source text, and the hazard is a loss of efficacy rather than direct toxicity or contamination. Per the severity rubric, recalls involving labeling errors or specification failures without reported harm typically score 2 (Moderate).

Plain-English summary

Professional Disposables International, Inc. is recalling PDI Povidone-Iodine Prep Pad Large (NDC 10819-3883-3) distributed nationwide in the United States. The recall affects 1982 cases. The product is subpotent, meaning the concentration of the active ingredient povidone-iodine is out of specification and below the required level.

This topical antiseptic prep pad is used to disinfect skin before medical procedures. When subpotent, it may not provide adequate antimicrobial protection, potentially compromising the intended antiseptic efficacy.

Affected lot numbers include: 11801215 (EXP 2021-08-22), 11801504 (EXP 2021-11-06), 11801717 (EXP 2021-12-07), 11900421 (EXP 2022-04-04), 11901076 (EXP 2022-08-29), 11901571 (EXP 2022-11-19), 12000388 (EXP 2023-03-13), 12001533 (EXP 2023-07-28), and 12100459 (EXP 2024-03-31).

Consumers and healthcare facilities should stop using affected lots immediately. Those who have used this product should contact their healthcare provider with questions about whether additional precautions are needed.

The recalled product

Product
PVP IODINE PREP PAD (PROVIDONE IODINE)
Brand
PVP IODINE PREP PAD
Manufacturer
Professional Disposables International, Inc
Category
Drug — Topical Antiseptic
Hazard
Affected units
1,982

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Lot #'s 11801215
  • EXP 2021-08-22
  • 11801504
  • EXP 2021-11-06
  • 11801717
  • EXP 2021-12-07
  • 11900421
  • EXP 2022-04-04
  • 11901076
  • EXP 2022-08-29
  • 11901571
  • EXP 2022-11-19
  • 12000388
  • EXP 2023-03-13
  • 12001533 EXP 2023-07-28
  • 12100459 EXP 2024-03-31

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Professional Disposables International, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same brand · PVP IODINE PREP PAD

Same manufacturer · Professional Disposables International, Inc

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Same hazard · subpotent active ingredient

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