“Padagis Nystatin Cream Recall: Subpotent Drug Risk.” GovInfoNow, updated August 9, 2026. https://govinfonow.com/recall/31193-padagis-nystatin-cream-recall-subpotent-drug-risk. Based on FDA recall #D-0677-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0677-2026%22&limit=1).
Padagis US LLC recalled Nystatin Cream USP, 15 g tubes nationwide on June 23, 2026, according to the FDA. The product may be subpotent due to low assay results from stability testing.
How to tell if you have it
Brand: Padagis
Product: Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube
NDC: 45802-059-35
Lot #: 205060
Expiration: 09/30/2027
Quantity: 180,936 tubes
The hazard
The recall involves subpotent drug risk caused by low out-of-specification assay results during long-term stability testing. The FDA classified this as a Class II voluntary recall.
Context
GovInfoNow's records show Padagis US LLC has had 7 other recalls since December 27, 2021. Recent similar recalls include Blaine Labs TERPENICOL Antifungal Cream (April 8, 2026), Unichem busPIRone 5mg Tablets (April 13, 2026), and CoValence Laboratories Remedy Gel Hydrocortisone 1% (March 18, 2026). FDA's FAERS database contains 26,038 adverse-event reports naming NDC 45802-059, with 20,294 marked serious and 3,611 listing a death.
How to tell if you have this one
Look for the 15g tube labeled 'Nystatin Cream USP (100,000 USP Nystatin Units)' manufactured by Padagis in Israel. The product was sold with NDC 45802-059-35 and Lot #205060, expiring September 30, 2027.
Brand
Padagis
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product label matches the recalled Nystatin Cream USP (15g tube) with NDC 45802-059-35 and Lot #205060.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0677-2026 (June 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0677-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 9, 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.