Calendula Cream — Class III drug recall D-0803-2018
Terminated recall by Boiron Inc., reported 2018-05-23, distributed nationwide. Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients
| Recall number | D-0803-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boiron Inc., Newtown Square, PA, United States |
| Recall initiated | 2018-04-13 |
| Classified | 2018-05-11 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2020-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 52,810 tubes |
| Reason classes | labeling, potency |
| Lot numbers | M7090709, M7090711, M7090712, M7090713, M7090807, M7110589 |
| Expiration dates | 2019-09, 2019-11 |
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%.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0803-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.