# FDA recall D-1329-2022

> **AVKARE Inc.** · Class III · drug recall initiated 2022-07-20.

## Product

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

## Reason for recall

Labeling: Label Error on Declared Strength

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1329-2022
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-20
- **Report date:** 2022-08-17
- **Termination date:** 2024-09-30

- **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-1329-2022

## Citation

> AI Analytics. FDA recall D-1329-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-1329-2022. Source: US FDA. Licensed CC0.

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