# FDA recall D-0803-2018

> **Boiron Inc.** · Class III · drug recall initiated 2018-04-13.

## Product

Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

## Reason for recall

Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%.  The primary packaging (tube) correctly states the active ingredient at 10%.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0803-2018
- **Recalling firm:** Boiron Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-13
- **Report date:** 2018-05-23
- **Termination date:** 2020-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newtown Square, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2018

## Citation

> AI Analytics. FDA recall D-0803-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0803-2018. Source: US FDA. Licensed CC0.

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