# FDA recall D-1289-2020

> **AVKARE Inc.** · Class III · drug recall initiated 2020-05-28.

## Product

Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.

## Reason for recall

Presence of Foreign Substance consistent with granules from desiccant packs used during storage

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-1289-2020
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-05-28
- **Report date:** 2020-06-10
- **Termination date:** 2021-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1289-2020

## Citation

> AI Analytics. FDA recall D-1289-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-1289-2020. Source: US FDA. Licensed CC0.

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