Ketoconazole Shampoo (Tolmar) – Subpotent Formulation (2013)
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
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Brand
Tolmar, Inc.
Lot Codes / Batch Numbers
Lots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14, 6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14, and 6123A exp 10/14
Products Sold
Lots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14,6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14,and 6123A exp 10/14
Tolmar, Inc. is recalling Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, due to Subpotent. 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
Subpotent
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 10, 2026