CLASS III Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report
Clobetasol Propionate Foam, 0.05%, a) pack recalled
Glenmark Pharmaceuticals Inc., USA is recalling Clobetasol Propionate Foam, 0.05%, a) pack (, distributed nationwide in the US. The recall was initiated on 15 Nov 2019 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-0618-2020
- FDA event ID
- 84282
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Nov 2019
- FDA classified
- 10 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 15 Nov 2019 | Recall initiated by company | |
| 10 Dec 2019 | Classified by FDA | +25 days |
| 18 Dec 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective delivery system; product is not foaming or is coming out as liquid.
Product as listed by the FDA
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective delivery system; product is not foaming or is coming out as liquid.
Which lots are affected?
a) 14190026, 14190028, 14190029, exp Feb-2021, 14190043, 14190045 exp Apr-2021 b) 14190024, 14190025, 14190027, exp Feb-2021, 14190030, 14190031, exp Mar-2021, 14190039, 14190042 exp Apr-2021, 14190047 exp May-2021, 14190062 exp Jul-2021
Where was it sold?
Nationwide
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.
Other products in this recall event
1 other product · FDA event 84282| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) pack recalledClobetasol Propionate | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Clobetasol Propionate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Ointment, USP, 0.05% tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Cream recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Clobetasol propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Lotion 0.05%, Generic for Temovate recalled | Preferred Pharmaceuticals | Potency & Assay | IL |