The Recall Desk
ModerateFDA (Drugs)·D-0760-2021·Announced 2021-09-01

PVP Iodine Prep Pads Recalled for Potency Below Specification

Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.

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: The source text does not report any illness or injury. The FDA classification is Class II. The hazard is a manufacturing defect (subpotency) that is a quality issue rather than a direct safety threat, making this a moderate precautionary recall.

Plain-English summary

Professional Disposables International, Inc. is recalling PVP Iodine Prep Pads (povidone iodine swabsticks) because the product is subpotent and out of specification. This means the concentration of the active ingredient does not meet the FDA's required standards for effectiveness.

The affected product is PDI Povidone Iodine Swabstick (1's), manufactured by Professional Disposables International, Inc. in Orangeburg, NY, with NDC 10819-3885-1. A total of 41,105 cases were distributed nationwide in the United States. The recall includes multiple lot numbers with expiration dates ranging from July 2021 through April 2023.

Consumers and healthcare facilities that have received affected batches should stop using the product and contact the manufacturer for further instructions. Healthcare providers should also verify that their inventory does not contain the recalled lot numbers.

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
41,105

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 (20)

  • Lot #'s 11900790
  • EXP 2021-07-25
  • 11900919
  • EXP 2021-07-28
  • 11900920
  • EXP 2021-08-12
  • 11900921
  • EXP 2021-08-15
  • 11901106
  • EXP 2021-08-27
  • 11901107
  • EXP 2021-08-30
  • 11901128
  • EXP 2021-09-05
  • 11901129
  • EXP 2021-09-12
  • 11901249
  • EXP 2021-09-25
  • 11901250
  • EXP 2021-10-17

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 · subpotency

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