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.
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 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
- Hazard
- subpotency
- out-of-specification
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.
Related recalls
Same brand · PVP IODINE PREP PAD
- ModeratePVP Iodine Prep Pads Recalled for Potency Below Specification
FDA (Drugs) · 2021-09-01
- 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
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