The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0066-2025·Announced 2024-12-04

FDA Recalls Menthol Medicated Patches Due to Manufacturing Deviations

FDA recalls THERA CARE COLD HOT MEDICATED PATCH (menthol 5%) due to manufacturing practice deviations. The voluntary recall affects 279,936 patches distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: This is a voluntary, precautionary FDA Class II recall with no reported illnesses or injuries. The hazard involves manufacturing process deviations rather than a specific product contamination, and no health impacts have been documented.

Plain-English summary

THERA CARE COLD HOT MEDICATED PATCH, containing 5% menthol, is a topical over-the-counter drug product manufactured by Unexo Life Sciences Private Limited for Veridian Healthcare, LLC. The product is packaged with 5 patches per box. Approximately 279,936 patches have been affected by this recall and were distributed nationwide in the United States.

The FDA initiated this Class II recall due to current good manufacturing practice (cGMP) deviations identified at the manufacturing facility. cGMP violations indicate the manufacturer did not follow FDA-required standards for drug manufacturing processes.

Consumers can identify affected product using the UPC code 8 45717 00818 1 and NDC number 71101-954-05. The manufacturer voluntarily initiated the recall on October 24, 2024. The recall was terminated by the FDA on September 16, 2025.

The recalled product

Product
THERA CARE COLD HOT MEDICATED PATCH (MENTHOL)
Brand
THERA CARE COLD HOT MEDICATED PATCH
Manufacturer
Unexo Life Sciences Private Limited
Category
Drug — Topical Over-the-Counter
Hazard
Affected units
279,936

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 (1)

  • UPC 8 45717 00818 1

UPCs (2)

  • 0845717008181
  • 845717008181

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Unexo Life Sciences Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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