# FDA recall D-1095-2023

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2023-08-14.

## Product

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

## Reason for recall

Subpotent: Out of Specification for Assay Test at the 3-month time point.

## Distribution

nationwide in the U.S.

## Key facts

- **Recall number:** D-1095-2023
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-08-14
- **Report date:** 2023-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1095-2023

## Citation

> AI Analytics. FDA recall D-1095-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1095-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*