Food, drugs, devices › Glenmark Pharmaceuticals Inc., USA
Drug recall: Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufa
FDA enforcement event 84282 is a drug recall by Glenmark Pharmaceuticals Inc., USA of Mahwah, NJ, initiated 15 Nov 2019 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 15 Mar 2024. Initiation: voluntary: firm initiated. Glenmark Pharmaceuticals Inc., USA has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ.
Reason for recall
"Defective delivery system; product is not foaming or is coming out as liquid."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0618-2020 | 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 | a) 34521 bottles; b) 16930 bottles | Class III | Terminated | 18 Dec 2019 |
| D-0619-2020 | Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ… | a) 480 packs; b) 240 packs | Class III | Terminated | 18 Dec 2019 |
Context
Other enforcement events for Glenmark Pharmaceuticals Inc., USA
All 55 events for Glenmark Pharmaceuticals Inc., USA
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective delivery system; product is not foaming or is coming out as liquid."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Mar 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.