# FDA recall D-1492-2016

> **Lupin Limited** · Class III · drug recall initiated 2016-02-19.

## Product

Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09

## Reason for recall

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

## Distribution

US      No recalled product was distributed to any foreign consignees by Lupin.

## Key facts

- **Recall number:** D-1492-2016
- **Recalling firm:** Lupin Limited
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-19
- **Report date:** 2016-09-14
- **Termination date:** 2017-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Verna, Salcette, Goa, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1492-2016

## Citation

> AI Analytics. FDA recall D-1492-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1492-2016. Source: US FDA. Licensed CC0.

---

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