Ketoconazole Shampoo — Class III drug recall D-66402-001
Terminated recall by Tolmar, Inc., reported 2013-10-30, distributed nationwide. Subpotent
| Recall number | D-66402-001 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tolmar, Inc., Fort Collins, CO, United States |
| Recall initiated | 2013-09-23 |
| Classified | 2013-10-18 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 391,055 bottles |
| Reason classes | potency |
| NDC | 00781-7090-04 |
| Lot numbers | 1/14, 10/13, 10/14, 11/13, 12/13, 2/14, 3/14, 4/14, 5307A, 5391A, 5392A, 5393A, 5394A, 5396A, 5430A, 5431A, 5432A, 5434A, 5490A, 5491A, 5492A, 5493A, 5494A, 5495A, 5523A, 5531A, 5533A, 5534A, 5535A, 5578A, 5617A, 5619A, 5621A, 5660A, 5661A, 5689A, 5690A, 5728A, 5776A, 6111A and 14 more |
Product
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Reason for recall
Subpotent
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-66402-001. 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.