Lupin Pharmaceuticals Inc. recalls Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin
Lupin Pharmaceuticals recalls Nystatin and Triamcinolone Acetonide Cream due to failed content uniformity tests at 9 months. This may affect product stability and safety for patients using prescription medication.
Lower-risk recall
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling a specific prescription cream product because testing showed inconsistent drug content over time. This could mean the medication isn't working properly for patients who need it. Read more at govinfonow.com/recall/38272-lupin-nystatin-cream-recall-failed-content-uniformity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38272-lupin-nystatin-cream-recall-failed-content-uniformity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1518-2019
Cite this page
“Lupin Nystatin Cream Recall: Failed Content Uniformity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38272-lupin-nystatin-cream-recall-failed-content-uniformity-risk. Based on FDA recall #D-1518-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1518-2019%22&limit=1).
Why it’s dangerous
The cream failed uniformity tests after 9 months of storage in upright orientation. This means the medication content may vary between different parts of the tube, potentially affecting treatment effectiveness.
Who’s affected
Patients with a prescription for this specific cream are affected. Those using the product for medical treatment are most at risk due to potential inconsistent medication levels.
How to tell if you have this one
Check for the product name 'Nystatin and Triamcinolone Acetonide Cream USP' with 15g tube size. It was manufactured by Lupin with specific lot numbers and expiration dates listed in the recall notice.
- Brand
Lupin- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, 15g tube size, and lot numbers (K800245, K900036, K900153) on the packaging.
Questions people ask
Is this cream safe to use?
The recall states the product failed uniformity tests, which may affect medication consistency. Patients should not use it until the recall remedy is followed.
What should I do if I have this cream?
The recall does not specify a remedy, so contact Lupin Pharmaceuticals for guidance on next steps.
How can I tell if I have the recalled product?
Check for the product name 'Nystatin and Triamcinolone Acetonide Cream USP', 15g tube, and lot numbers K800245, K900036, or K900153.
Contact Lupin
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-1518-2019 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-1518-2019 from Lupin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1518-2019 (July 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1518-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.