The Recall Desk
ModerateFDA (Drugs)·D-0409-2021·Announced 2021-06-02

Cardinal Health Recalls Lidocaine HCL Visc 2% Due to Temperature Excursions

Cardinal Health Inc. is recalling 240 bottles of Lidocaine HCL Visc 2% 100ml due to intermittent temperature excursions during storage.

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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation (temperature excursion) without reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling 240 bottles of Lidocaine HCL Visc 2% 100ml (NDC/UPC 50383077504). The product is a prescription solution. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code is 373577.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return or dispose of the medication.

The recalled product

Product
LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
Affected units
240

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)

  • 373577

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →