Mentholatum Recalls WellPatch Capsaicin Patches Due to Labeling Error
The Mentholatum Company is recalling WellPatch Capsaicin Pain Relief Patches because the word 'not' was missing from safety instructions, potentially leading to improper use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error that could lead to improper use, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
The Mentholatum Company is recalling 80,208 pouches of WellPatch Capsaicin Pain Relief Patches, 0.025% Natural Capsaicin, External Analgesic. The product was distributed nationwide through Walmart stores. The recall involves specific lot numbers EL016, EL 026, EL036, and EL046, all with an expiration date of 12/2016.
The recall was initiated due to a labeling error in the Drug Facts panel. The word "not" was missing from two sentences in the "Warning" section: "do bandage tightly or cover with any type of wrap except clothing" and "do use with a heating pad or with other heat sources." This omission could lead consumers to misunderstand the safety instructions regarding the application of the patches.
Consumers with these specific lot numbers should stop using the product and return it to the place of purchase for a refund. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- 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 31
- Manufacturer
- The Mentholatum Co.
- Category
- Drug — Topical Analgesic
- Hazard
- Affected units
- 80,208
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot numbers: EL016
- EL 026
- EL036
- EL046
- Expiration Date: 12/2016
Distribution
Distributed nationwide across the United States.
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