Teva Pharmaceuticals USA recalls Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT,
Teva recalls 0.01% Fluocinolone Acetonide Topical Solution 60mL bottles due to failed impurities and degradation tests. This may affect drug safety and efficacy. Contact Teva for details.
Lower-risk recall
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
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What happened, in plain English
Teva Pharmaceuticals is recalling 60mL bottles of Fluocinolone Acetonide Topical Solution (0.01%) because lab tests found impurities and degradation issues. This could mean the medication isn't working properly or is unsafe for use. Read more at govinfonow.com/recall/40383-teva-fluocinolone-acetonide-topical-solution-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40383-teva-fluocinolone-acetonide-topical-solution-recall-failed-impurities-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0909-2018
Cite this page
“Teva Fluocinolone Acetonide Topical Solution Recall: Failed Impurities Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40383-teva-fluocinolone-acetonide-topical-solution-recall-failed-impurities-risk. Based on FDA recall #D-0909-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0909-2018%22&limit=1).
Why it’s dangerous
The medication failed lab tests for impurities and degradation. This means the product might not work as intended or could be unsafe for skin use. The issue is detected through quality control checks.
Who’s affected
People with prescriptions for this topical solution are affected. Those using the medication for skin conditions may be at risk if the product is not effective.
How to tell if you have this one
Check for 60mL bottles labeled 'Fluocinolone Acetonide Topical Solution, USP, 0.01%'. The product was manufactured by Actavis Laboratories in Utah with specific lot numbers and expiration dates listed in the recall.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, size (60mL), and lot numbers listed in the recall notice.
Questions people ask
Is this product safe to use?
The recall indicates the product failed quality tests, so it may not be safe or effective. Do not use until confirmed safe by the manufacturer.
How do I know if I have the recalled product?
Check for 60mL bottles with lot numbers 1164898 (exp 10/18), 1164904, 1164909 (exp 11/18), 1211396 (exp 07/19), or 1230808, 1231127 (exp 01/20).
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Teva Pharmaceuticals for guidance on next steps.
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0909-2018 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0909-2018 from Teva Pharmaceuticals. 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-0909-2018 (July 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0909-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.