Novel Labs Recalls Fluocinolone Acetonide Solution Due to Contamination
Novel Laboratories recalls 7,656 bottles of Fluocinolone Acetonide Topical Solution due to chemical contamination. Check your lot numbers.
Use caution until it’s fixed
Chemical Contamination
Contact the company
What happened, in plain English
Novel Laboratories, Inc. is recalling Fluocinolone Acetonide Topical Solution USP 0.01% because it contains a chemical contamination. The recall affects 7,656 bottles distributed nationwide. This product is for topical use only and is not intended for ophthalmic use. Read more at govinfonow.com/recall/41918-novel-labs-recalls-fluocinolone-acetonide-solution-due-to-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/41918-novel-labs-recalls-fluocinolone-acetonide-solution-due-to-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-0653-2017
Cite this page
“Novel Labs Recalls Fluocinolone Acetonide Solution Due to Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41918-novel-labs-recalls-fluocinolone-acetonide-solution-due-to-contamination. Based on FDA recall #D-0653-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2017%22&limit=1).
Why it’s dangerous
The product is subject to recall due to chemical contamination, which poses a potential health risk to users. The specific nature of the contamination or its direct medical consequences are not detailed in the provided record.
Who’s affected
Consumers who purchased Fluocinolone Acetonide Topical Solution USP 0.01% in 60 mL bottles from nationwide distributors between the manufacturing dates and expiration dates listed below are affected. Patients using this prescription medication for skin conditions are at risk of exposure to the contaminated product.
How to tell if you have this one
Check if you have a 60 mL bottle of Fluocinolone Acetonide Topical Solution USP 0.01% manufactured for Gavis Pharmaceuticals, LLC. Look for NDC 43386-069-60 and one of the following lot numbers: M15496 (Expiration 10/17) or M15507 (Expiration 12/17).
- Brand
Novel Laboratories- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle matches the NDC and lot numbers listed in the recall details.
Contact Manufacturer
Since no specific remedy is stated, contact Novel Laboratories or Gavis Pharmaceuticals for instructions on how to proceed with the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0653-2017 (February 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0653-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.