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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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FDA (Drugs) · 2021-09-01
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FDA (Drugs) · 2021-09-01
- ModeratePVP Iodine Prep Pads Recalled for Potency Below Specification
FDA (Drugs) · 2021-09-01
Same manufacturer · Professional Disposables International, Inc
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- ModeratePDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency
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FDA (Drugs) · 2021-09-01
Same hazard · subpotent active ingredient
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Similar recalls
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FDA (Drugs) · 2018-02-07
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- SevereMedline Povidone-Iodine Prep Pads Recalled for Subpotent Iodine Content
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- SeverePurdue Pharma Recalls Betadine Swabsticks Due to Subpotent Drug Hazard
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