G & W Recalls Ciclopirox Olamine Cream Due to Discoloration
G & W Laboratories recalls specific lots of Ciclopirox Olamine Cream USP, 0.77% due to intermittent yellow discoloration. Check your tube's lot number and expiration date.
Recall notice
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Contact the company
What happened, in plain English
G & W Laboratories is recalling Ciclopirox Olamine Cream USP, 0.77% because the product may have intermittent yellow discoloration instead of the expected white to off-white color. The recall covers 142,236 tubes distributed nationwide in the USA and Puerto Rico. The record does not state a specific remedy or what consumers should do with the affected product. Read more at govinfonow.com/recall/40920-g-w-recalls-ciclopirox-olamine-cream-due-to-discoloration.
Source Summary by GovInfoNow · govinfonow.com/recall/40920-g-w-recalls-ciclopirox-olamine-cream-due-to-discoloration · Updated October 11, 2026 · FDA enforcement record: FDA #D-0250-2018
Cite this page
“G & W Recalls Ciclopirox Olamine Cream Due to Discoloration.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40920-g-w-recalls-ciclopirox-olamine-cream-due-to-discoloration. Based on FDA recall #D-0250-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0250-2018%22&limit=1).
Why it’s dangerous
The hazard is that the cream may have intermittent yellow discoloration rather than being a white to off-white homogenous cream. The recall record does not explain why this discoloration is dangerous or if it affects the drug's safety or efficacy.
Who’s affected
Consumers who purchased Ciclopirox Olamine Cream USP, 0.77% from pharmacies or retailers nationwide in the USA and Puerto Rico before January 19, 2018. The record does not specify which health conditions this medication treats or who is most at risk.
How to tell if you have this one
Check your tube for the National Drug Code (NDC) numbers: 0713-0638-15, 0713-0638-31, or 0713-0638-18. Look for lot numbers such as 1002896, 1005797, 1006100, 1002561, 1002897, 1005798, 1006101, 1002898, 1004283, 1005837, 1006321, or 1006322. Verify the expiration dates listed in the record (ranging from June 2018 to July 2019) and check if the cream has yellow discoloration.
- Brand
G & W Laboratories- Category
Drug
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 2 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.
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-0250-2018 (January 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0250-2018 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.