Food, drugs, devices › Glenmark Pharmaceuticals Inc., USA
Drug recall: Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured
Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ) initiated this drug recall on 14 Aug 2023; FDA lists 1 product record under event 92859, classified Class III.
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. 26% of the 281 drug enforcement events initiated in 2023 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, Mahwah, NJ.
Reason for recall
"Subpotent: Out of Specification for Assay Test at the 3-month time point."
Distribution
"nationwide in the U.S."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1095-2023 | Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01 | 1,200 bottles | Class III | Ongoing | 30 Aug 2023 |
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: "Subpotent: Out of Specification for Assay Test at the 3-month time point."
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 U.S."
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.