Calendula Cream (Boiron) – Incorrect Ingredient Labeling (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Brand
Boiron Inc.
Lot Codes / Batch Numbers
Lot Numbers: M7090711, M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019
Products Sold
Lot Numbers: M7090711, M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019
Boiron Inc. is recalling Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtow due to Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active i. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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%.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026