# FDA recall D-0018-2016

> **The Mentholatum Co.** · Class II · drug recall initiated 2015-09-17.

## Product

WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China --- NDC 10742-8126-2, UPC 31074201566

## Reason for recall

Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section

## Distribution

Nationwide through Walmart stores.

## Key facts

- **Recall number:** D-0018-2016
- **Recalling firm:** The Mentholatum Co.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-17
- **Report date:** 2015-10-21
- **Termination date:** 2018-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orchard Park, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2016

## Citation

> AI Analytics. FDA recall D-0018-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0018-2016. Source: US FDA. Licensed CC0.

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