CLASS III Drug recall · Reported 11 Jul 2012 · FDA Enforcement Report
Balnetar Therapeutic Tar Bath, Coal Tar recalled by Ranbaxy
Ranbaxy is recalling Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), distributed nationwide in the US. The recall was initiated on 16 Mar 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1405-2012
- FDA event ID
- 61934
- Recalling firm
- Ranbaxy, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Mar 2012
- FDA classified
- 3 Jul 2012
- Reported
- 11 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Mar 2012 | Recall initiated by company | |
| 3 Jul 2012 | Classified by FDA | +109 days |
| 11 Jul 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Which lots are affected?
Lot #: RB81031, Exp 01/13
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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