Taro Pharmaceuticals Nystatin Cream Recall: Failed Content Uniformity
Taro Pharmaceuticals recalls Nystatin and Triamcinolone Acetonide Cream due to failed content uniformity tests. This could affect product stability and safety after 18 months.
Lower-risk recall
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Contact the company
What happened, in plain English
Taro Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream products that failed stability testing. These creams may not contain the correct amount of active ingredients after 18 months, potentially leading to ineffective treatment. Read more at govinfonow.com/recall/41780-taro-pharmaceuticals-nystatin-cream-recall-failed-content-uniformity.
Source Summary by GovInfoNow · govinfonow.com/recall/41780-taro-pharmaceuticals-nystatin-cream-recall-failed-content-uniformity · Updated October 8, 2026 · FDA enforcement record: FDA #D-0676-2017
Cite this page
“Taro Pharmaceuticals Nystatin Cream Recall: Failed Content Uniformity.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41780-taro-pharmaceuticals-nystatin-cream-recall-failed-content-uniformity. Based on FDA recall #D-0676-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0676-2017%22&limit=1).
Why it’s dangerous
The product failed content uniformity tests during stability testing. This means the active ingredients may not be present in the correct amounts after 18 months, which could lead to ineffective treatment but does not cause immediate harm.
Who’s affected
Patients prescribed these creams by a doctor are affected. Those using the product beyond its expiration date or after the 18-month stability period may be at higher risk.
How to tell if you have this one
Check for the Taro label on the cream tube. The product comes in 15g, 30g, or 60g sizes with specific lot numbers and expiration dates listed in the recall notice.
- Brand
Taro Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the Taro label and check the lot number and expiration date on the tube.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years 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.
Questions people ask
What should I do if I have this product?
The recall does not require immediate action. Check the product details and use it within the expiration date as the product is safe for its intended use.
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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-0676-2017 (March 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0676-2017 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.