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.
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: 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 →Related recalls
Same manufacturer · Unexo Life Sciences Private Limited
See all →- ModerateTopical menthol back patch recalled for manufacturing deviations
FDA (Drugs) · 2024-12-04
- ModerateParche Leon pain relief patches recalled for manufacturing deviations
FDA (Drugs) · 2024-12-04
- ModerateFDA Recalls Cheeky Bonsai Menthol Pain Relief Patches for Manufacturing Deviations
FDA (Drugs) · 2024-12-04
- ModerateJR Watkins Menthol Pain Relief Patches Recalled for Manufacturing Deviations
FDA (Drugs) · 2024-12-04
- ModerateAbsorbine Jr Pain Relieving Knee Patch recalled for manufacturing deviations
FDA (Drugs) · 2024-12-04
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-09
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12