# FDA recall D-0576-2020

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-12-02.

## Product

Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.

## Reason for recall

Presence of Foreign Substance: Presence of a foreign object in a single tablet.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0576-2020
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-02
- **Report date:** 2019-12-18
- **Termination date:** 2021-10-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salisbury, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2020

## Citation

> AI Analytics. FDA recall D-0576-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0576-2020. Source: US FDA. Licensed CC0.

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