Teligent Pharma, Inc. recalls Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60
Teligent Pharma recalls Fluocinonide Ointment 0.05% tubes due to impurity issues. This prescription ointment may contain unsafe levels of Fluocinolone Acetonide. Contact for details.
Recall notice
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Contact the company & request your remedy
What happened, in plain English
Teligent Pharma is recalling Fluocinonide Ointment 0.05% tubes because they contain unsafe levels of Fluocinolone Acetonide impurities. This could lead to health risks if used as directed. The product is prescription-only and available in 15g, 30g, and 60g tubes with specific lot numbers. Read more at govinfonow.com/recall/36759-teligent-pharma-fluocinonide-ointment-0-05-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36759-teligent-pharma-fluocinonide-ointment-0-05-recall-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0064-2021
Cite this page
“Teligent Pharma Fluocinonide Ointment 0.05% Recall: Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36759-teligent-pharma-fluocinonide-ointment-0-05-recall-impurity-risk. Based on FDA recall #D-0064-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0064-2021%22&limit=1).
Why it’s dangerous
The ointment contains unsafe levels of Fluocinolone Acetonide impurities, which can cause adverse health effects. This impurity may lead to skin irritation or other health issues when applied topically.
Who’s affected
Prescription users of Fluocinonide Ointment 0.05% in the specified tube sizes and lot numbers. Those with skin conditions requiring topical corticosteroids are most at risk.
How to tell if you have this one
Check for the product name 'Fluocinonide Ointment USP 0.05%' in 15g, 30g, or 60g tubes with the NDC numbers 52565-0040-15, 52565-0040-30, or 52565-0040-60. Look for specific lot numbers listed in the recall notice.
- Brand
Teligent Pharma- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, tube size, NDC number, and lot number to confirm if it's recalled.
Questions people ask
Is this product safe to use?
The recall indicates potential impurities that could cause health risks, so it's not safe to use as recalled.
What should I do if I have this product?
The recall does not specify a remedy, so contact Teligent Pharma for guidance on next steps.
How can I check if my product is recalled?
Check the product's NDC number (52565-0040-15, 52565-0040-30, or 52565-0040-60) and lot number against the list provided in the recall notice.
Contact Teligent Pharma
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0064-2021 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0064-2021 from Teligent Pharma. 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-0064-2021 (September 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0064-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.