# FDA recall D-0561-2024

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2024-06-04.

## Product

Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34

## Reason for recall

Subpotent Drug

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0561-2024
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-06-04
- **Report date:** 2024-06-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0561-2024

## Citation

> AI Analytics. FDA recall D-0561-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0561-2024. Source: US FDA. Licensed CC0.

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