CLASS III Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report
Xolegel (ketoconazole) gel 2% tubes recalled by Almirall
Almirall is recalling Xolegel (ketoconazole) gel 2% tubes, distributed nationwide in the US. The recall was initiated on 16 Sep 2022 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-1549-2022
- FDA event ID
- 90877
- Recalling firm
- Almirall, Malvern, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Sep 2022
- FDA classified
- 29 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 16 Sep 2022 | Recall initiated by company | |
| 29 Sep 2022 | Classified by FDA | +13 days |
| 5 Oct 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
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
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Which lots are affected?
Lot #: RGAF, Exp. Date 12/2022
Where was it sold?
Nationwide within the United States
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.