Balnetar Therapeutic Tar Bath — Class III drug recall D-1405-2012
Terminated recall by Ranbaxy Inc., reported 2012-07-11, distributed nationwide. Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
| Recall number | D-1405-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ranbaxy Inc., Princeton, NJ, United States |
| Recall initiated | 2012-03-16 |
| Classified | 2012-07-03 |
| Reported by FDA | 2012-07-11 |
| Terminated | 2013-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 2,544 bottles |
| Reason classes | potency |
| NDC | 10631-0106-08 |
| Lot numbers | 01/13, RB81031 |
Product
Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
Reason for recall
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
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-1405-2012. 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.