Ciclopirox Cream (G&W Laboratories) – Product Discoloration (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
G & W Laboratories, Inc.
Lot Codes / Batch Numbers
Lot #: a) 1002896, Exp 09/18, 1005797, Exp 05/19, 1006100, Exp 07/19, b) 1002561, Exp 06/18, 1002897, Exp 09/18, 1005798, Exp 05/19, 1006101, Exp 07/19, c) 1002898, Exp 10/18, 1004283, Exp 12/18, 1005837, Exp 05/19, 1006321, 1006322, Exp 07/19
Products Sold
Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19
G & W Laboratories, Inc. is recalling Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (ND due to Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026