CLASS III Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report
Capex Shampoo (fluocinolone acetonide), Topical Shampoo recalled
Galderma Laboratories is recalling Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, distributed nationwide in the US. The recall was initiated on 15 Aug 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-1660-2012
- FDA event ID
- 62803
- Recalling firm
- Galderma Laboratories, Fort Worth, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Aug 2012
- FDA classified
- 24 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 15 Aug 2012 | Recall initiated by company | |
| 24 Aug 2012 | Classified by FDA | +9 days |
| 5 Sep 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; fluocinolone acetonide.
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
Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Subpotent; fluocinolone acetonide.
Which lots are affected?
Lots J090181-H100089, J090181-J100096, and J090181-K100102.
Where was it sold?
Nationwide and Puerto Rico.
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.
More recalls from Galderma Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Doxycycline, USP Capsules 40 mg recalled by Galderma Laboratories | Galderma Laboratories | Packaging Defects | Nationwide |