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Class II: temporary or reversible health riskTerminated

Unexo Life Sciences Private Theracare Maximum Strength Pain Relief 4% Recall

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24

Unexo Life Sciences Private Limited

Risk level
Class II
Reported by FDA
Dec 4, 2024
Recall ID
D-0065-2025
Check your lot numberHow we source this data

Summary

Unexo Life Sciences Private recalled Theracare Maximum Strength Pain Relief 4% starting Oct 24, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0065-2025 on Dec 4, 2024. Reason: cGMP Deviations. Status: Terminated.

Why it was recalled

cGMP Deviations

Product description

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031

Lot numbers, UPCs & expiration codes

a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6

Where it was sold

Nationwide in the US

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0065-2025
Classification
Class II
Status
Terminated
Recall initiated
Oct 24, 2024
FDA report date
Dec 4, 2024
Quantity
455,536 patches
Recall type
Voluntary: Firm initiated
Recalling firm
Unexo Life Sciences Private Limited

Original FDA data

Every field from FDA enforcement report D-0065-2025, exactly as published.

Show all FDA fields
City
New Delhi
Status
Terminated
Country
India
Event ID
95595
Address
B16, Sector 4, Bawana Industrial Area
Code information
a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6
Report date
Dec 4, 2024
Product type
Drugs
Recall number
D-0065-2025
Classification
Class II
Recalling firm
Unexo Life Sciences Private Limited
Product quantity
455,536 patches
Termination date
Sep 16, 2025
Reason for recall
cGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031
Distribution pattern
Nationwide in the US
Recall initiation date
Oct 24, 2024
Initial firm notification
Letter
Center classification date
Nov 22, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0065-2025, published Dec 4, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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