# FDA recall D-0601-2024

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2024-06-28.

## Product

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.

## Reason for recall

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0601-2024
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-06-28
- **Report date:** 2024-07-24

- **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-0601-2024

## Citation

> AI Analytics. FDA recall D-0601-2024. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/D-0601-2024. Source: US FDA. Licensed CC0.

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