Lower risk Drug recall · FDA · Published July 23, 2021

PDI Duo-Swab Povidone-Iodine Swabstick Recall: Subpotent Quality Issue

Professional Disposables International recalls PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotent quality. This means the product may not contain enough active ingredient for intended use. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0764-2021Drug PDI ›

Lower-risk recall

SubPotent: Out of Specification

Take action

Contact the company

Recalling firmProfessional Disposables International, Inc400 Chestnut Ridge Rd · Woodcliff Lake, NJ 07677-7604

✎ GovInfoNow plain-language explainer

Professional Disposables International has recalled PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks because they may not contain enough active ingredient. This could affect the product's effectiveness for medical use. Read more at govinfonow.com/recall/36061-pdi-duo-swab-povidone-iodine-swabstick-recall-subpotent-quality-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/36061-pdi-duo-swab-povidone-iodine-swabstick-recall-subpotent-quality-issue · Updated August 18, 2026 · FDA enforcement record: FDA #D-0764-2021

Cite this page

“PDI Duo-Swab Povidone-Iodine Swabstick Recall: Subpotent Quality Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36061-pdi-duo-swab-povidone-iodine-swabstick-recall-subpotent-quality-issue. Based on FDA recall #D-0764-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0764-2021%22&limit=1).

The FDA announced on July 23, 2021, that Professional Disposables International, Inc. is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotent drug risks. The recall affects products distributed nationwide in the United States.

How to tell if you have it

Brand: PDI
Product: PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1
Reorder No: S23125
UPC: (01)00318019000161; SKU S23125
Lot codes: 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392 and 12100393
Quantity: 11,039 cases

The hazard

The recalled items are classified as subpotent and out of specification. The FDA listed the hazard as SubPotent: Out of Specification.

Context

GovInfoNow's records show Professional Disposables International, Inc. has one other recall on record since February 4, 2022. On February 4, 2022, the company issued a Prevantics Swabstick Recall due to manufacturing quality concerns involving cGMP deviations. Other recent recalls of similar products include ImprimisRx Povidone Iodine Ophthalmic Solution Recall (August 24, 2026), Specialty Process Labs Thyroid Product Recall (January 16, 2026), and BD PurPrep Sterile Solution Recall (April 22, 2026).

How to tell if you have this one

Check for the product name 'PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick' with NDC numbers 10819-3891-1 or 10819-3890-1. The recall includes specific lot numbers listed in the product description.

Brand
PDI
Category
Drug

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Distributed Nationwide in the US

Recall number	Product, codes & lots	Quantity	NDC
D-0758-2021	PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,; 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; 11900195 2022-02-19; 11900196 2022-02-21; 11900197 2022-02-25; 11900370 2022-04-01; 11900372 2022-04-03; 11900371 2022-04-05; 11900647 2022-05-04; 11900623 2022-05-21; 11900624 2022-05-24; 11900646 2022-05-29; 11900967 2022-08-13; 11900968 2022-08-26; 11900969 2022-08-28; 11901043 2022-09-11; 11901044 2022-09-18; 11901318 2022-10-03; 11901330 2022-10-08; 11901331 2022-10-16; 11901446 2022-10-28; 11901447 2022-11-19; 11901448 2022-12-19; 11901739 2023-01-02; 11901752 2023-01-09; 12000045 2023-01-14; 12000048 2023-01-18; 12000046 2023-01-21; 12000047 2023-01-24; 12000333 2023-01-25; 12000675 2023-02-16; 12000334 2023-02-27; 12000335 2023-02-27; 12000336 2023-02-28; 12000676 2023-03-16; 12000815 2023-03-29; 12000816 2023-05-05; 12000914 2023-05-13; 12000915 2023-05-18; 12000951 2023-05-22; 12000950 2023-06-01; 12001366 2023-08-12; 12001367 2023-08-14; 12001368 2023-08-17; 12001370 2023-08-21; 12001369 2023-08-21; 12001371 2023-08-25; 12001372 2023-09-30; 12001818 2023-09-30; 12001820 2023-09-30; 12001819 2023-11-30; 12001821 2023-11-30; 12001822 2023-11-30; 12001972 2023-12-31; 12001973 2023-12-31; 12001974 2023-12-31; 12001975 2023-12-31; 12001976 2023-12-31; 12001977 2023-12-31; 12001978 2023-12-31; 12100080 2023-12-31; 12100081 2023-12-31; 12100082 2024-02-29; 12100084 2024-02-29; 12100447 2024-03-31; 11800978, 11800979, 11801123, 11801124, 11801125, 11801126, 11801228, 11801230, 11801231, 11801232, 11801234, 11801417,11801418, 11801419, 11801420, 11801421, 11801709, 11801710, 11900195, 11900196, 11900197, 11900370, 11900371, 11900372, 11900623, 11900624, 11900646, 11900647, 11900967, 11900968, 11900969, 11901043, 11901044, 11901318, 11901330, 11901331, 11901446, 11901447, 11901448, 11901739, 11901752, 12000045, 12000046, 12000047, 12000048, 12000333, 12000334, 12000335, 12000336, 12000675, 12000676, 12000815, 12000816, 12000914, 12000915, 12000950, 12000951, 12001366, 12001367, 12001368, 12001369, 12001370, 12001371, 12001372, 12001818, 12001819, 12001820, 12001821, 12001822, 12001972, 12001973, 12001974, 12001975, 12001976, 12001977, 12001978, 12100080, 12100081, 12100082, 12100084 and 12100447	53588 cases	10819-3883-1, 10819-3883-3, 10819-3885-1, 10819-3885-2, 0031081900
D-0759-2021	PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154; Lot #'s 11801215, EXP 2021-08-22; 11801504, EXP 2021-11-06; 11801717,EXP 2021-12-07; 11900421, EXP 2022-04-04; 11901076, EXP 2022-08-29; 11901571, EXP 2022-11-19; 12000388, EXP 2023-03-13; 12001533 EXP 2023-07-28; 12100459 EXP 2024-03-31;	1982 cases	10819-3883-1, 10819-3883-3, 10819-3885-1, 10819-3885-2, 0031081900
D-0760-2021	PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.; 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; 11901391, EXP 2021-10-19; 11901392, EXP 2021-10-22; 11901438, EXP 2021-10-24; 11901439, EXP 2021-10-08; 11901457, EXP 2021-11-07; 11901541, EXP 2021-11-18; 11901603, EXP 2021-11-19; 11901604, EXP 2021-12-19; 11901669, EXP 2021-12-19; 11901670, EXP 2021-11-16; 11901702, EXP 2021-12-02; 11901703, EXP 2021-12-14; 12000082, EXP 2021-12-19; 12000083, EXP 2022-01-24; 12000118, EXP 2022-01-03; 12000119, EXP 2022-01-30; 12000249, EXP 2022-01-10; 12000250, EXP 2022-01-10; 12000348, EXP 2022-02-13; 12000349, EXP 2022-02-28; 12000398, EXP 2022-02-05; 12000456, EXP 2022-03-12; 12000457, EXP 2022-03-12; 12000683, EXP 2022-03-23; 12000684, EXP 2022-03-30; 12000685, EXP 2022-04-04; 12000922, EXP 2022-05-15; 12000923, EXP 2022-05-19; 12000927, EXP 2022-05-21; 12000989, EXP 2022-06-15; 12000990, EXP 2022-06-05; 12000991, EXP 2022-06-10; 12001154, EXP 2022-06-26; 12001155, EXP 2022-06-24; 12001231, EXP 2022-07-26; 12001232, EXP 2022-07-21; 12001243, EXP 2022-07-03; 12001244, EXP 2022-07-04; 12001537, EXP 2022-08-31; 12001538, EXP 2022-08-31; 12001539, EXP 2022-08-31; 12001540, EXP 2022-09-30; 12001666, EXP 2022-09-30; 12001667, EXP 2022-09-30; 12001668, EXP 2022-09-30; 12001669, EXP 2022-09-30; 12001841, EXP 2022-10-31; 12001842, EXP 2022-10-31; 12001959, EXP 2022-10-31; 12002072, EXP 2022-11-30; 12100123, EXP 2023-02-28; 12100124, EXP 2023-02-28; 12100454, EXP 2023-03-31; 12100455, EXP 2023-03-31; 12100590, EXP 2023-04-30; 12100591, EXP 2023-04-30;	41,105 cases	10819-3883-1, 10819-3883-3, 10819-3885-1, 10819-3885-2, 0031081900
D-0761-2021	PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185; 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; 11901180, EXP 2022-11-13; 11901247, EXP 2022-11-14; 11901248, EXP 2022-11-15; 11901388, EXP 2022-11-16;11901389, EXP 2022-11-17; 11901390, EXP 2022-11-18; 11901419, EXP 2022-11-19; 11901420, EXP 2022-11-20; 11901480, EXP 2022-11-21; 11901558, EXP 2022-11-22;11901590, EXP 2022-11-23; 11901591, EXP 2022-11-24; 11901592, EXP 2022-11-25; 11901691, EXP 2022-11-26; 11901692, EXP 2022-11-27; 12000054, EXP 2022-11-28; 12000055, EXP 2022-11-29; 12000116, EXP 2022-11-30; 12000117, EXP 2022-12-01; 12000172, EXP 2022-12-02; 12000173, EXP 2022-12-03; 12000189, EXP 2022-12-04; 12000190, EXP 2022-12-05; 12000287, EXP 2022-12-06; 12000288, EXP 2022-12-07; 12000346, EXP 2022-12-08; 12000347, EXP 2022-12-09; 12000452, EXP 2022-12-10; 12000453, EXP 2022-12-11; 12000454, EXP 2022-12-12; 12000455, EXP 2022-12-13; 12000679, EXP 2022-12-14; 12000680, EXP 2022-12-15; 12000681, EXP 2022-12-16; 12000682, EXP 2022-12-17; 12000881, EXP 2022-12-18; 12000882, EXP 2022-12-19; 12000883, EXP 2022-12-20; 12000884, EXP 2022-12-21; 12001003, EXP 2022-12-22; 12001004, EXP 2022-12-23; 12001005, EXP 2022-12-24; 12001006, EXP 2022-12-25; 12001150, EXP 2022-12-26; 12001151, EXP 2022-12-27; 12001184, EXP 2022-12-28; 12001283, EXP 2022-12-29; 12001284, EXP 2022-12-30; 12001285, EXP 2022-12-31; 12001510, EXP 2023-01-01; 12001513, EXP 2023-01-02; 12001514, EXP 2023-01-03; 12001515, EXP 2023-01-04; 12001598, EXP 2023-01-05; 12001599, EXP 2023-01-06; 12001600, EXP 2023-01-07; 12001786, EXP 2023-01-08; 12001789, EXP 2023-01-09; 12001790, EXP 2023-01-10; 12001843, EXP 2023-01-11; 12001844, EXP 2023-01-12; 12001981, EXP 2023-01-13; 12001982, EXP 2023-01-14; 12002006, EXP 2023-01-15; 12002007, EXP 2023-01-16; 12002148, EXP 2023-01-17; 12002149, EXP 2023-01-18; 12100119, EXP 2023-01-19; 12100120, EXP 2023-01-20; 12100237, EXP 2023-01-21; 12100238, EXP 2023-01-22; 12100239, EXP 2023-01-23; 12100240, EXP 2023-01-24; 12100456, EXP 2023-01-25; 12100457, EXP 2023-01-26; 12100537, EXP 2023-01-27;	51,926 cases	10819-3883-1, 10819-3883-3, 10819-3885-1, 10819-3885-2, 0031081900
D-0762-2021	PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.; Lot #'s 11901081, EXP 2023-04-04; 11901340, EXP 2023-04-05; 11901593, EXP 2023-04-06; 11901594, EXP 2023-04-07; 12000784, EXP 2023-04-08; 12000992, EXP 2023-04-09; 12001492, EXP 2023-04-10; 12001699, EXP 2023-04-11; 12100121, EXP 2023-04-12; 12100453, EXP 2023-04-13;	5,477 cases	—
D-0763-2021	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.; 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;	3,113 cases	—
D-0764-2021	PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161; SKU S23125 Lot #'s 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392 and 12100393	11,039 cases	—

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Professional Disposables International for specific instructions on how to handle the recalled swabsticks.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Jul 23, 2021Firm started the recall
Aug 20, 2021FDA classified it Class II
Sep 1, 2021Published in FDA’s Enforcement Report
May 31, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any safety risks from using this product?

The recall indicates a potential reduction in effectiveness, but there are no immediate safety risks like injury or illness.

Similar recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36061-pdi-duo-swab-povidone-iodine-swabstick-recall-subpotent-quality-issue">PDI Duo-Swab Povidone-Iodine Swabstick Recall: Subpotent Quality Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0764-2021 (July 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0764-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.