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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: 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.
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 403
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.
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