Food, drugs, devices › Glenmark Pharmaceuticals Inc., USA
Drug recall: Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-87
FDA enforcement event 98036 is a drug recall by Glenmark Pharmaceuticals Inc., USA of Elmwood Park, NJ, initiated 21 Nov 2025 and classified Class III, with 1 product record.
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. 12% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. 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, Elmwood Park, NJ.
Reason for recall
"Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe"
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0199-2026 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda.… | 11,136 bottles | Class III | Ongoing | 10 Dec 2025 |
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: "Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe"
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 in the USA"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.