G&W Laboratories Ciclopirox Cream Recall: Out-of-Date Package Insert
G&W Laboratories recalls Ciclopirox Olamine Cream USP 0.77% tubes with outdated package inserts. This labeling issue may lead to incorrect use. Consumers should check lot numbers and contact the manufacturer for details.
Lower-risk recall
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Contact the company
What happened, in plain English
G&W Laboratories is recalling Ciclopirox Olamine Cream USP 0.77% tubes that came with outdated or missing package inserts. This labeling error could lead to incorrect use of the medication, especially since it's a prescription product. Read more at govinfonow.com/recall/41805-g-w-laboratories-ciclopirox-cream-recall-out-of-date-package.
Source Summary by GovInfoNow · govinfonow.com/recall/41805-g-w-laboratories-ciclopirox-cream-recall-out-of-date-package · Updated October 8, 2026 · FDA enforcement record: FDA #D-0636-2017
Cite this page
“G&W Laboratories Ciclopirox Cream Recall: Out-of-Date Package Insert.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41805-g-w-laboratories-ciclopirox-cream-recall-out-of-date-package. Based on FDA recall #D-0636-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0636-2017%22&limit=1).
Why it’s dangerous
The product was packaged with an outdated or missing package insert. This labeling issue could lead to incorrect use of the medication, especially since it's a prescription product that requires proper instructions.
Who’s affected
Prescription users of Ciclopirox Olamine Cream USP 0.77% tubes. Those with the specific lot numbers listed in the recall are most at risk due to potential incorrect use.
How to tell if you have this one
Check the tube size (15g, 30g, or 90g) and the lot number on the packaging. The recalled lots include specific expiration dates and numbers listed in the recall notice.
- Brand
G&W Laboratories- Category
Drug
What to do — step by step
Check Package Insert
Look for an outdated or missing package insert on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA 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 11 months 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.
Questions people ask
How do I know if my product is recalled?
Check the tube size and lot number against the list provided in the recall notice.
Similar recalls
Latest drug recalls
Keep exploring
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-0636-2017 (March 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0636-2017 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.