Ciclopirox Olamine Cream USP — Class III drug recall D-0250-2018
Terminated recall by G & W Laboratories, Inc., reported 2018-02-14, distributed nationwide. Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yello
| Recall number | D-0250-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | G & W Laboratories, Inc., South Plainfield, NJ, United States |
| Recall initiated | 2018-01-19 |
| Classified | 2018-02-02 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-02-03 |
| Distributed | Nationwide (US) |
| Quantity | 142,236 tubes |
| NDC | 00713-0638, 00713-0638-15, 00713-0638-18, 00713-0638-31 |
Product
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Reason for recall
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0250-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.