# FDA recall D-0108-2021

> **Heritage Pharmaceuticals Inc** · Class III · drug recall initiated 2020-10-23.

## Product

Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01

## Reason for recall

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0108-2021
- **Recalling firm:** Heritage Pharmaceuticals Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-23
- **Report date:** 2020-12-02
- **Termination date:** 2022-01-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2021

## Citation

> AI Analytics. FDA recall D-0108-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0108-2021. Source: US FDA. Licensed CC0.

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