Boiron Recalls Calendula Cream Due to Labeling Error
Boiron Inc. recalls specific lots of Calendula Cream because the outer carton incorrectly states the active ingredient concentration as 7% instead of 10%.
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%.
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What happened, in plain English
Boiron Inc. is recalling 52,810 tubes of Calendula Cream distributed nationwide due to a labeling error on the secondary packaging. The outer cartons for specific lots misstate the concentration of the active ingredient (calendula officinalis) as 7%, while the tube itself correctly lists it as 10%. This is classified as a Class III recall, which typically involves products unlikely to cause adverse health consequences but violate FDA labeling regulations. Read more at govinfonow.com/recall/40616-boiron-recalls-calendula-cream-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/40616-boiron-recalls-calendula-cream-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0803-2018
Cite this page
“Boiron Recalls Calendula Cream Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40616-boiron-recalls-calendula-cream-due-to-labeling-error. 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 hazard is strictly a labeling discrepancy where the outer box claims a lower concentration (7%) than what is actually in the tube (10%). The record does not indicate that the product itself is unsafe, contaminated, or ineffective; rather, the issue is that the packaging information does not match the declared strength.
Who’s affected
Consumers who purchased Boiron Calendula Cream in 2.5 oz. tubes from nationwide retailers between the production dates of the affected lots and before their expiration dates (September or November 2019).
How to tell if you have this one
Check your 2.5 oz. tubes of Boiron Calendula Cream for the following lot numbers: M7090711, M7090712, M7090713, M7090709, M7090807 (Expiration: 09/2019) and M7110589 (Expiration: 11/2019). Verify that the outer carton states the active ingredient is 7% while the tube states 10%.
- Brand
Boiron- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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 qwen3.6:35b-a3b on October 11, 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.