CLASS II Drug recall · Reported 21 Oct 2015 · FDA Enforcement Report
WellPatch¿ Capsaicin Pain Relief Patch recalled by The Mentholatum
The Mentholatum is recalling WellPatch¿ Capsaicin Pain Relief Patch, 025% Natural Capsaicin, External Analgesic, 4, distributed nationwide in the US. The recall was initiated on 17 Sep 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0018-2016
- FDA event ID
- 72246
- Recalling firm
- The Mentholatum, Orchard Park, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2015
- FDA classified
- 14 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Sep 2015 | Recall initiated by company | |
| 14 Oct 2015 | Classified by FDA | +27 days |
| 21 Oct 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
Nationwide through Walmart stores.
Stores named: Walmart
Questions about this recall
Is WellPatch¿ Capsaicin Pain Relief Patch, 025% Natural Capsaicin, External Analgesic, 4 recalled?
Yes. The Mentholatum recalled WellPatch¿ Capsaicin Pain Relief Patch, 025% Natural Capsaicin, External Analgesic, 4 on 17 Sep 2015. The recall is Class II and its status is Terminated. Recall number D-0018-2016.
Why was it recalled?
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
Which lots are affected?
Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016
Where was it sold?
Nationwide through Walmart stores.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Mentholatum
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%) recalledRed Cross Oral Pain Relief | The Mentholatum | Packaging Defects | Nationwide |
| Drug | CLASS II | Rohto Redness Relief, Cool, Redness Reliever recalled by The Mentholatum | The Mentholatum | Sterility | Nationwide |
| Drug | CLASS II | Rohto Redness Relief, ice, Redness Reliever, Lubricant recalled | The Mentholatum | Sterility | Nationwide |
| Drug | CLASS II | Rohto Redness Relief, arctic, Redness Reliever recalled | The Mentholatum | Sterility | Nationwide |
| Drug | CLASS II | Rohto Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net recalled | The Mentholatum | Sterility | Nationwide |