Lidocaine Patch 5% Recalled for Temperature Exposure During Distribution
McKesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during storage and distribution. Affected patches may not function properly. Patients should consult their healthcare provider.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for cGMP deviations (temperature abuse) affecting pharmaceutical product storage and stability. Temperature exposure to medication patches poses a risk to drug stability and efficacy. No illnesses or injuries reported. Meets High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Lidocaine Patch 5%, 30-count boxes (NDC 42858-0118-30), distributed nationwide in the United States. The recall was initiated due to cGMP deviations involving temperature abuse during storage and distribution of the product.
Patches exposed to temperatures outside appropriate ranges may have compromised stability and integrity. This could affect the patch's ability to deliver the prescribed dose of lidocaine effectively and safely as intended.
Patients currently using recalled product should consult their healthcare provider before stopping treatment or continuing use. Healthcare providers and pharmacists who have distributed or dispensed this product should stop dispensing immediately and follow McKesson's recall instructions.
The recalled product
- Product
- Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Patch
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
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- ModerateCVS Lidocaine Cold and Hot Patch Recalled for Manufacturing Record Loss
FDA (Drugs) · 2020-06-03
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateEquate Maximum Strength Lidocaine Pain Relieving Patches Recalled for Manufacturing Deviations
FDA (Drugs) · 2024-12-04
- ModerateMcKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2017-04-19
- ModerateMylan Amiodarone Hydrochloride Injection Recalled for Temperature Abuse
FDA (Drugs) · 2014-10-15
- ModeratePreferred Pharmaceuticals Recalls Lidothol Patches Due to Missing Batch Records
FDA (Drugs) · 2020-07-22