Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Clobetasol Propionate Emollient Cream 0.05%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
Affected NDCs
50383-0270-30
50383-0270-60
Compare with the code on your package — it is the most precise check available.
Drug: Clobetasol
- Recalling firm
- Akorn Inc
- NDC code
- 50383-270-30
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0515-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clobetasol recalls
See all
Class II · Moderate risk
Clobetasol Propionate Shampoo
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Ointment
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Cream
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Clobetasol propionate Cream USP
Subpotent Drug: Low assay result observed during long-term stability testing.
Other recalls by Akorn Inc
All 2019 recalls
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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