PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported October 21, 2015

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

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…

Recall #
D-0018-2016
Affected scope
80,208 pouches
Initiated
September 17, 2015
Verify with FDA Drug →
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The Mentholatum Co. recalled WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 L… - a moderate-severity action.

WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 L… was recalled by The Mentholatum Co. in October 21, 2015. Reason: Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly …. Check the official notice for the remedy. Verify recall #D-0018-2016 with the FDA Drug before acting.

The recall

The Mentholatum Co. issued this moderate-severity FDA Drug recall-Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly ….

Moderate
severity level
Class II
classification
October 21, 2015
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0018-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0018-2016
Date reported October 21, 2015
Date initiated September 17, 2015
Recalling firm The Mentholatum Co.
Firm location Orchard Park, NY
Affected scope 80,208 pouches
Distribution Nationwide through Walmart stores.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0018-2016) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by The Mentholatum Co.. Units affected: 80,208 pouches.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Drug on October 21, 2015. Severity: Moderate. Recall number: D-0018-2016.
Where was the recalled product distributed?
Distribution: Nationwide through Walmart stores..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported October 21, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026