# FDA recall D-0329-2021

> **Macleods Pharma Usa Inc** · Class III · drug recall initiated 2021-03-22.

## Product

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0329-2021
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-22
- **Report date:** 2021-04-21
- **Termination date:** 2022-12-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0329-2021

## Citation

> AI Analytics. FDA recall D-0329-2021. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/D-0329-2021. Source: US FDA. Licensed CC0.

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