PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.
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 product is classified as FDA Class II. The recall is based on subpotency (out-of-specification active ingredient), a quality defect with no reported illnesses or injuries. This is a precautionary action and falls under the Moderate category per the rubric.
Plain-English summary
Professional Disposables International, Inc. is recalling PDI Povidone-Iodine Swabsticks (3's) distributed nationwide in the United States. The product is classified as a topical antiseptic antiseptic intended for skin preparation prior to injections or medical procedures.
The recall has been initiated because the product is subpotent and out of specification. This means the active ingredient (povidone-iodine) level is below the required standard, which may affect the product's ability to provide the intended antiseptic effect.
Affected lot numbers span from 11900761 (expiration 2022-11-03) through 12100537 (expiration 2023-01-27), with a total of 51,926 cases distributed. Healthcare facilities and other users who have this product should stop using affected lots and contact the manufacturer or their supplier for replacement stock.
Consumers and healthcare providers with questions about the recall are encouraged to contact Professional Disposables International, Inc. The FDA is monitoring the situation.
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
- 51,926
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 11900761
- EXP 2022-11-03
- 11900917
- EXP 2022-11-04
- 11900918
- EXP 2022-11-05
- 11901008
- EXP 2022-11-06
- 11901009
- EXP 2022-11-07
- 11901124
- EXP 2022-11-08
- 11901125
- EXP 2022-11-09
- 11901126
- EXP 2022-11-10
- 11901127
- EXP 2022-11-11
- 11901179
- EXP 2022-11-12
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
- ModeratePVP Iodine Prep Pads Recalled for Potency Below Specification
FDA (Drugs) · 2021-09-01
- ModeratePDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient
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
- ModerateBetadine Povidone-Iodine Solution Swabstick recalled for subpotent drug
FDA (Drugs) · 2021-09-29
- ModerateMedline Recalls Povidone-Iodine Prep Pads Due to Low Iodine Content
FDA (Drugs) · 2018-02-07
- SeverePurdue Pharma Recalls Betadine Swabsticks Due to Subpotent Drug Hazard
FDA (Drugs) · 2017-11-15
- ModeratePovidone-iodine antiseptic solution recalled after testing subpotent in one lot
FDA (Drugs) · 2025-10-01
- ModerateMedline Recalls Subpotent Povidone-Iodine Scrub Solution Bottles
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- ModeratePrevantics Swabstick Chlorhexidine Recall Due to Test Validation Uncertainty
FDA (Drugs) · 2022-03-02