Teva Recalls Lidocaine Patches Due to Missing Lot and Expiration Dates
Teva Pharmaceuticals is recalling Lidocaine 5% Patches because individual pouches are missing lot and expiration dates. The recall covers 28,596 cartons distributed nationwide.
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: The recall is classified as FDA Class II and involves a labeling error (missing lot/expiration dates) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Teva Pharmaceuticals USA is recalling Lidocaine 5% Patches, packaged in 30-count cartons, due to a labeling defect. The individual transdermal pouches within the cartons are missing or have incorrect lot and expiration dates, although the carton itself contains the correct information. The affected product is identified by Carton Lot # 1383513B, Patch Lot # 1383513, and an expiration date of 03/2022.
The recall involves 28,596 cartons of the prescription-only medication, which was distributed nationwide in the United States. The product was manufactured by Actavis Laboratories UT, Inc., and distributed by Actavis Pharma, Inc.
Consumers and healthcare providers should stop using the affected Lidocaine 5% Patches and contact their pharmacist or healthcare provider for a replacement or refund. This recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- LIDOCAINE (LIDOCAINE)
- Brand
- LIDOCAINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 28,596
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 (3)
- Carton Lot # 1383513B
- Patch Lot # 1383513
- Exp date 03/2022
Distribution
Distributed nationwide across the United States.
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