X-Gen Nystatin Powder Recall: Plastic Particles Risk
X-Gen Pharmaceuticals recalls Nystatin topical powder due to potential plastic particles. Affected lots: 23701.158A, expiring 10/31/18. Stop using if you have this product.
Use caution until it’s fixed
Presence of Foreign Substance: potential presence of plastic particles.
Contact the company
What happened, in plain English
X-Gen Pharmaceuticals is recalling Nystatin Topical Powder because it may contain plastic particles. This could cause injury if the powder gets into the eyes or skin. The recall affects specific lots with the expiration date of 10/31/2018. Read more at govinfonow.com/recall/41619-x-gen-nystatin-powder-recall-plastic-particles-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41619-x-gen-nystatin-powder-recall-plastic-particles-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-1059-2017
Cite this page
“X-Gen Nystatin Powder Recall: Plastic Particles Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41619-x-gen-nystatin-powder-recall-plastic-particles-risk. Based on FDA recall #D-1059-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1059-2017%22&limit=1).
Why it’s dangerous
The product may contain plastic particles that could get into the eyes or skin during use. This could cause irritation, injury, or infection if the particles are not properly removed.
Who’s affected
People who have the recalled Nystatin Topical Powder (15g bottles) with lot number 23701.158A, expiring 10/31/2018. Those using the product for skin or eye treatments are most at risk if plastic particles are present.
How to tell if you have this one
Check the product label for the lot number 23701.158A and expiration date 10/31/2018. The product is a 15g bottle of Nystatin Topical Powder, prescription-only.
- Brand
X-Gen Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number 23701.158A and expiration date 10/31/2018 on the bottle.
Stop Using if Recalled
If you have the recalled lot, stop using the product immediately to avoid potential injury.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1059-2017 (May 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1059-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.