THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH recall
FDA recall D-0065-2025 · initiated Oct 24, 2024
Unexo Life Sciences Private Limited recalled THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH in Oct 2024 — an FDA Class II recall (D-0065-2025) because cGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 455,536 patches
Details
- Product
- 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
- Recalling company
- Unexo Life Sciences Private Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Oct 24, 2024
- FDA report date
- Dec 4, 2024
Frequently asked
- Was THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH recalled?
- Unexo Life Sciences Private Limited recalled THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH in Oct 2024 — an FDA Class II recall (D-0065-2025) because cGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH recalled?
- Per the FDA enforcement record, the reason for recall D-0065-2025 was: cGMP Deviations
- Is a recalled THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH are affected?
- Distributed: Nationwide in the US. The recall covers these lots — a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0065-2025.