CLASS II Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report
Clobetasol Propionate Foam recalled by Ingenus Pharmaceuticals
Ingenus Pharmaceuticals is recalling Clobetasol Propionate Foam, 0.05%, distributed nationwide in the US. The recall was initiated on 10 Jan 2022 and the FDA has classified it as Class II.
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-0374-2022
- FDA event ID
- 89393
- Recalling firm
- Ingenus Pharmaceuticals, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2022
- FDA classified
- 14 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 10 Jan 2022 | Recall initiated by company | |
| 14 Jan 2022 | Classified by FDA | +4 days |
| 26 Jan 2022 | 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
CGMP Deviations
Product as listed by the FDA
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
a) Lots: 32921 Exp. 06/2022; 33152 Exp. 08/2022; 33340 Exp. 11/2022; b) Lots: 33152 Exp. 08/2022; 33340 Exp. 11/2022.
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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