Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Clobetasol propionate Cream USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Low assay result observed during long-term stability testing.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Affected NDC
68180-0956-03
Compare with the code on your package — it is the most precise check available.
Drug: Clobetasol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clobetasol Propionate NDC 68180-0956 |
.5 mg/g | Cream Topical |
Lupin Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-956-03
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0174-2023 · 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 II · Moderate risk
Clobetasol Propionate Lotion 0.05%
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Other recalls by Lupin Pharmaceuticals Inc.
All 2023 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
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