Ciclopirox Olamine Cream USP — Class III drug recall D-0636-2017
Terminated recall by G & W Laboratories, Inc., reported 2017-04-12, distributed nationwide. Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
| Recall number | D-0636-2017 |
|---|---|
| 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 | 2017-03-20 |
| Classified | 2017-04-04 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2018-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 230,700 tubes |
| Reason classes | labeling |
| 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 Plainfeld, NJ 07080.
Reason for recall
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
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-0636-2017. 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.