The Recall Desk
ModerateFDA (Drugs)·D-0556-2023·Announced 2023-05-10

Lidocaine Patch 5% Recalled for Typographical Error on Label

Bryant Ranch Prepack is recalling Lidocaine Patch 5% nationwide due to a typographical error on product labels. The labels incorrectly state 'tablet' instead of 'patch', creating potential confusion about the dosage form.

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: This FDA Class III recall involves a minor labeling error on the product packaging. The medication itself is not defective; only the label text incorrectly describes the dosage form as 'tablet' instead of 'patch'. FDA Class III recalls with minor labeling errors are typically scored as Moderate (2) severity.

Plain-English summary

Bryant Ranch Prepack, Inc. is recalling Lidocaine Patch 5% due to a typographical error on the product labeling. Approximately 403 boxes were distributed nationwide.

The error appears on both the outer carton and individual patch labels. The text incorrectly states "each tablet contains" instead of the correct description "each adhesive patch contains." Each patch contains 700 mg of lidocaine.

The incorrect dosage form description could cause confusion among patients and healthcare providers about how the medication should be used.

Patients currently using affected patches should not be alarmed, as the medication itself is not defective. Those with affected lot numbers should contact their pharmacy or healthcare provider with questions.

The recalled product

Product
LIDOCAINE (LIDOCAINE)
Brand
LIDOCAINE
Manufacturer
Bryant Ranch Prepack, Inc.
Hazard
  • label-error

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 (20)

  • Lot: 204603
  • Exp: 09/30/2024
  • Lots:208608
  • 208749
  • 208445
  • 209101
  • 208609
  • 208295
  • 209106
  • 209102
  • 209212
  • 208975
  • 209211
  • 209706
  • 209779
  • 209624
  • 209839
  • 209548
  • Exp: 12/31/2024
  • Lots: 204604

Distribution

Distributed nationwide across the United States.