PDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength 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: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is reduced efficacy of a topical antiseptic cleansing product rather than contamination or structural failure. The recall is being conducted proactively without evidence of patient harm.
Plain-English summary
Professional Disposables International, Inc. is recalling PDI Povidone-Iodide Cleansing Scrub Swabstick (3's) with NDC 10819-3891-3. The recall affects approximately 3,113 cases distributed nationwide in the United States.
The product is being recalled because it is subpotent—the povidone-iodide active ingredient does not meet the required potency specification. This means the product may not provide the intended cleansing efficacy. Affected lot numbers are 11901080 (expiration 2023-04-14), 11901339 (expiration 2023-04-15), 11901755 (expiration 2023-04-16), 12000016 (expiration 2023-04-17), 12000397 (expiration 2023-04-18), 12000987 (expiration 2023-04-19), 12001578 (expiration 2023-04-20), and 12001814 (expiration 2023-04-21).
Consumers and healthcare providers who have this product should stop using it and contact Professional Disposables International, Inc. for instructions on return or replacement.
The recalled product
- Product
- PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
- Manufacturer
- Professional Disposables International, Inc
- Category
- Drug — Topical Antiseptic
- Affected units
- 3,113
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 11901080
- EXP 2023-04-14
- 11901339
- EXP 2023-04-15
- 11901755
- EXP 2023-04-16
- 12000016
- EXP 2023-04-17
- 12000397
- EXP 2023-04-18
- 12000987
- EXP 2023-04-19
- 12001578
- EXP 2023-04-20
- 12001814
- EXP 2023-04-21
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
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