FDA Drug recall D-0018-2016
WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor
- FDA Drug
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor by The Mentholatum, citing 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 heat….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0018-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-17 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Mentholatum |
| Distribution | US |
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
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
Identifiers
| code_info | Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0018-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.