# FDA recall D-0012-2019

> **InvaGen Pharmaceuticals, Inc.** · Class III · drug recall initiated 2018-10-03.

## Product

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323  UPC 369097128159, NDC 69097-128-15

## Reason for recall

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month  long term stability condition.

## Distribution

Nationwide with the United States

## Key facts

- **Recall number:** D-0012-2019
- **Recalling firm:** InvaGen Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-10-03
- **Report date:** 2018-10-17
- **Termination date:** 2021-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2019

## Citation

> AI Analytics. FDA recall D-0012-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0012-2019. Source: US FDA. Licensed CC0.

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