FDA Recalls Prescription Lidocaine Patch Due to Temperature Exposure
McKesson Medical-Surgical is recalling Lidocaine Patch 5% nationwide due to temperature abuse during distribution that may have compromised product quality. The FDA classified this as a Class II recall.
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: FDA Class II recall with no reported illnesses or injuries. The hazard involves a manufacturing deviation (temperature exposure) during distribution, which is precautionary in nature and does not represent a direct threat to patient safety.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Lidocaine Patch 5% (Rx only) manufactured by Qualitest Products. The recall affects product distributed nationwide across the United States.
The FDA classified this as a Class II recall due to cGMP deviations involving temperature abuse during distribution. Temperature exposure may have affected the product's integrity and quality.
No illnesses or injuries have been reported in connection with this recall. Patients and healthcare providers should contact McKesson Medical-Surgical or their healthcare provider with questions about affected product.
The recalled product
- Product
- LIDOCAINE (LIDOCAINE)
- Brand
- LIDOCAINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →Related recalls
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