CLASS II ONGOING Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report
Lexette (halobetasol propionate) Topical Foam, 0.05% canisters recalled
Mayne Pharma is recalling Lexette (halobetasol propionate) Topical Foam, 0.05% canisters, distributed nationwide in the US. The recall was initiated on 14 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-0387-2022
- FDA event ID
- 89397
- Recalling firm
- Mayne Pharma, Greenville, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jan 2022
- FDA classified
- 19 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 14 Jan 2022 | Recall initiated by company | |
| 19 Jan 2022 | Classified by FDA | +5 days |
| 26 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Product as listed by the FDA
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Which lots are affected?
Lot #: 32451 Exp. 03/2022; 32532 Exp. 04/2022; 32552 Exp. 05/2022; 32701 32733 Exp. 10/2022; 32855 Exp. 02/2023; 32872 Exp. 03/2023.
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 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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