Boiron Inc. recalls Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Boiron recalls calendula cream tubes with incorrect labeling of active ingredient concentration. The product may contain less than stated strength, but no safety risks are reported.
Lower-risk 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%.
Contact the company & request your remedy
What happened, in plain English
Boiron is recalling calendula cream tubes that have a labeling error on the outer packaging. The outer carton incorrectly states the active ingredient concentration as 7% when it should be 10%. This means the product may have less active ingredient than labeled, but there are no safety risks reported. Read more at govinfonow.com/recall/40616-boiron-calendula-cream-10-product-labeling-error-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/40616-boiron-calendula-cream-10-product-labeling-error-recall · Updated October 7, 2026 · FDA enforcement record: FDA #D-0803-2018
Cite this page
“Boiron Calendula Cream 10% Product Labeling Error Recall.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40616-boiron-calendula-cream-10-product-labeling-error-recall. Based on FDA recall #D-0803-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0803-2018%22&limit=1).
Why it’s dangerous
The outer carton incorrectly states the active ingredient concentration as 7% when it should be 10%. This labeling error means the product may contain less active ingredient than labeled. However, the recall does not indicate any safety risks or injuries.
Who’s affected
People who own or use the recalled calendula cream tubes with specific lot numbers and expiration dates. Those most at risk are users who rely on the product for medical purposes.
How to tell if you have this one
Check for calendula cream tubes with lot numbers M7090711, M7090712, M7090713, M7090709, M7090807 (expiring 09/2019) or M7110589 (expiring 11/2019).
- Brand
Boiron- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers listed in the recall notice to confirm if your product is affected.
Questions people ask
Is this product dangerous?
No safety risks are reported in this recall. The issue is a labeling error, not a safety hazard.
What should I do if I have the recalled product?
The recall does not specify a remedy, so no action is required beyond checking the product label.
Why was this product recalled?
The outer carton incorrectly states the active ingredient concentration as 7% when it should be 10%, but there are no safety risks reported.
Contact Boiron
We’ve drafted a message you can send Boiron to request your refund or repair — edit it as you like.
Subject: Recall D-0803-2018 — Boiron Boiron Hello, I own a Boiron that is covered by recall D-0803-2018 from Boiron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0803-2018 (April 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0803-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.