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.
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: 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
- 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
- ModeratePVP Iodine Prep Pads Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2021-09-01
- ModeratePDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2021-09-01
- ModeratePDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency
FDA (Drugs) · 2021-09-01
Same manufacturer · Professional Disposables International, Inc
See all →- ModeratePrevantics Swab Drug Recall for Test Method Validation Deficiency
FDA (Drugs) · 2022-03-02
- ModeratePrevantics Maxi Swabstick Recall Due to Manufacturing Validation Issues
FDA (Drugs) · 2022-03-02
- ModeratePrevantics Swabstick Chlorhexidine Recall Due to Test Validation Uncertainty
FDA (Drugs) · 2022-03-02
- ModeratePDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency
FDA (Drugs) · 2021-09-01
- ModeratePDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency
FDA (Drugs) · 2021-09-01
Same hazard · subpotency
See all →- SeverePfizer Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-10-28
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
Similar recalls
- ModerateMedline Recalls Povidone-Iodine Prep Pads Due to Low Iodine Content
FDA (Drugs) · 2018-02-07
- ModeratePovidone-iodine antiseptic solution recalled after testing subpotent in one lot
FDA (Drugs) · 2025-10-01
- SeverePurdue Pharma Recalls Betadine Swabsticks Due to Subpotent Drug Hazard
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- ModerateBetadine Povidone-Iodine Solution Swabstick recalled for subpotent drug
FDA (Drugs) · 2021-09-29
- ModerateMedline Recalls Subpotent Povidone-Iodine Scrub Solution Bottles
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- SevereMedline Recalls Pediatric IV Kits With Subpotent Iodine Concentration
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