PVP Iodine Prep Pads Recalled for Subpotent Active Ingredient
Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is reduced antiseptic effectiveness due to subpotency, which is a safety concern but represents a precautionary action rather than an acute or high-risk threat. The source text does not report any confirmed harm or clinical adverse events.
Plain-English summary
Professional Disposables International, Inc. is recalling PVP Iodine Prep Pads distributed nationwide in the United States. The recalled product is a medium-sized prep pad (2.0 x 2.5 inches) used for skin antisepsis before medical procedures.
The recall is being conducted because the product is subpotent and out of specification, meaning it contains less povidone-iodine (the active ingredient) than required. This deficiency may reduce or eliminate the antimicrobial effectiveness of the prep pads.
Approximately 53,588 cases have been distributed. The affected product has multiple lot numbers with expiration dates ranging from July 2021 through March 2024. A complete list of affected lot numbers is available from the FDA and the manufacturer.
Consumers and healthcare providers should stop using affected products and contact Professional Disposables International for instructions on return or replacement. Healthcare facilities should check their inventory against the lot number list provided by the manufacturer and FDA.
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
- subpotent-active-ingredient
- reduced-efficacy
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 EXP date 11800977
- 2021-07-31
- 11800978 2021-08-02
- 11800979 2021-08-04
- 11801123 2021-08-06
- 11801124 2021-08-09
- 11801125 2021-08-15
- 11801126 2021-08-16
- 11801228 2021-08-28
- 11801230 2021-09-11
- 11801231 2021-09-13
- 11801232 2021-09-18
- 11801234 2021-10-25
- 11801417 2021-10-28
- 11801418 2021-11-01
- 11801419 2021-11-07
- 11801420 2021-11-15
- 11801421 2021-11-20
- 11801709 2021-11-29
- 11801710 2021-12-04
UPCs (15)
- 118009792021
- 118012282021
- 118014192021
- 118017092021
- 119001972022
- 119003712022
- 119006472022
- 119006232022
- 119009682022
- 119013302022
- 119014462022
- 120000482023
- 120013662023
- 120019772023
- 121000822024
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PVP IODINE PREP PAD
- ModeratePDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency
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
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